Meeting Details:

On March 20, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists of three major components: the delivery catheter, the steerable sleeve, and the MitraClip device. The MitraClip device is a single sized, percutaneously implanted mechanical clip for the reduction of mitral regurgitation. The MitraClip device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The implantable MitraClip device is fabricated with metal alloys and polyester fabric (Clip cover) that are commonly used in cardiovascular implants. The proposed indication for use: The MitraClip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR=3) in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing comorbidities would not preclude the expected benefit from correction of the mitral regurgitation.

Meeting Details:

On December 5, 2012, during session I, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for the external counter-pulsating (ECP) devices, one of the remaining pre-Amendment Class III devices. These systems typically consist of a treatment table, pressure cuffs and a controller. They are intended to provide noninvasive circulatory support by applying external pressure to the lower extremities during diastole to increase coronary perfusion pressure, and releasing external pressure during systole to reduce left ventricular workload.On December 5, 2012, during session II, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for Intra-aortic balloon and control systems, one of the remaining pre-Amendment Class III devices. Intra-aortic balloon pump (IABP) systems consist of an inflatable balloon and a console which inflates in synchronization with the cardiac cycle. During diastole, the balloon will inflate, creating a rise in pressure in the aorta, thus increasing blood flow to the coronary arteries and increasing myocardial oxygen supply. During systole, deflation of the balloon causes a fall in pressure in the aorta, which assists the left ventricle by reducing the pressure that needs to be generated to achieve ejection through the aortic valve.On December 6, 2012, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for Nonroller-type cardiopulmonary bypass blood pumps, one of the remaining pre-Amendment Class III devices. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump blood. There are two types of nonroller-type pumps which have been reviewed by the Agency: 1) Centrifugal type pumps utilize a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. These pumps are part of an extracorporeal circuit usually containing an oxygenator and are intended to provide cardiopulmonary support, during procedures such as cardiopulmonary bypass surgery, for periods lasting 6 hours or less. 2) Micro-axial type pumps are comprised of a pump motor, a cannula and a catheter that connects to a console. These pumps are not designed to be used with an oxygenator but are temporarily placed within the heart or vasculature to provide cardiac support only.

Meeting Details:

On June 13, 2012, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN Transcatheter Heart Valve is indicated for use in patients with symptomatic severe aortic stenosis who have high operative risk.

Meeting Details:

On May 24, 2012, the committee will discuss current knowledge about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD) occluders used for the closure of secundum atrial septal defects. The AMPLATZER Septal Occluder (ASO) Device was the first device introduced to the US market in 2001 followed by the Gore HELEX device in 2006. With more widespread use of these devices, more information has become available regarding adverse events. These events range from rare life-threatening events to more common events that are perceived to have less severe clinical sequelae. Many of these events were evident in the premarket studies; however, rare events such as erosion were not seen. The purpose of discussion of these events is: (1) to discuss the significance of these events in the overall context of the disease and existing treatment options; (2) to discuss whether additional measures should be taken to improve protection of the public health (e.g., additional study and/or data analyses, labeling changes); and (3) to communicate to patients and physicians what is and is not known about device treatment options.

Meeting Details:

On April 25, 2012, the committee will discuss, make recommendations and vote on information related to a supplement to the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS) sponsored by HeartWare, Inc. The HVAS is an implantable electrically powered centrifugal-flow rotary blood pump with external driver and power source(s). It is the first ventricular assist device that does not require the creation of an abdominal pump pocket. The HVAS is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory, advanced heart failure. On April 26, 2012, the committee will discuss, make recommendations and vote on information related to the PMA for the Subcutaneous Implantable Cardioverter Defibrillator (S–ICD) System sponsored by Cameron Health, Inc. The S–ICD is the first implantable defibrillator that does not require the implantation of an electrode either on or in the heart. The S–ICD is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias. The device is capable of delivering high energy defibrillation shocks as well as bradycardia demand mode cardiac pacing. The study provides data from the treatment of induced acute and chronic episodes of ventricular tachycardia/ventricular fibrillation and spontaneous episodes. In addition to the investigational device exemption study, clinical data were also obtained from using studies outside the United States and registries.

Meeting Details:

On December 7, 2011, the committee will discuss, make recommendations, and vote on information related to a supplement tothe premarket approval application (PMA) P010031, sponsored by Medtronic, Inc. Medtronic is requesting FDA approval to expand the indications for use for all commercially available Medtronic Cardiac Resynchronization Therapy Defibrillator (CRT¨CD) devices covered under PMA P010031. The company has proposed the following expanded indication statement based on the results of the REVERSE and RAFT clinical studies: ¡®¡®Medtronic cardiac resynchronization therapy defibrillator (CRT¨CD) systems are indicated for heart failure patients who meet the following classification: NYHA Functional Class II who remain symptomatic despite stable, optimal medical therapy, and who have left bundle branch block (LBBB) with a QRS duration ¡Ý120 ms, and left ventricular ejection fraction ¡Ü30%.¡¯¡¯ On December 8, 2011, the committee will discuss, make recommendations, and vote on information related to the PMA for the CardioMEMS HF Pressure Measurement System (HF System) sponsored by CardioMEMS, Inc. The CardioMEMS HF System is a permanently implantable pressure measurement system designed to provide daily pulmonary arterial pressure measurements including systolic, diastolic, and mean pulmonary artery pressure. These measurements are used to guide treatment of congestive heart failure.

Meeting Details:

On October 26, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of atrial fibrillation in patients who are undergoing open concomitant cardiac surgery. The AtriCure Synergy Ablation System consists of the following: The AtriCure Isolator Synergy Handpieces (models OLL2 and OSL2), which resemble surgical clamps, include a syringe-type grip handle/actuator, connected by a cylindrical shaft to a pair of grasping jaws with electrodes on each jaw. The electrodes deliver radiofrequency (RF) energy to the tissue grasped by the jaws. The Ablation and Sensing Unit is an RF generator used to power the Isolator Synergy Handpieces. The Isolator Switch Matrix is an accessory interface module allowing the Isolator Synergy Handpieces to connect to the RF generator. On October 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Medtronic Ablation Frontiers Cardiac Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation Frontiers Cardiac Ablation System is a catheter-based device developed for the treatment of atrial fibrillation. The system consists of the following: The Pulmonary Vein Ablation Catheter, which is designed to create lesions in the left atrium via five pairs of electrodes to isolate the pulmonary veins. It has a deflectable distal end and bidirectional steering to aid in positioning the catheter appropriately.

Meeting Details:

On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN\TM\ Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper. On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to-transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).

Meeting Details:

On January 25, 2011, the committee will discuss and make recommendations regarding regulatory classification of Automated External Defibrillators to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class II (subject to premarket notification (510(k))), as directed by section 515(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e(i)). On January 26, 2011, the committee will discuss, make recommendations and vote on information related to the PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX Acculink is indicated for treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined as follows: 1. Patients with neurological symptoms and >50 percent stenosis of the common or internal carotid artery or patients without neurological symptoms and >80 percent (high risk) or >70 percent (standard risk) stenosis of the common or internal carotid artery and 2. Patients must have a reference vessel diameter within the range of 4.0 and 9.0 mm at the target lesion.

Meeting Details:

On March 18, 2010, the committee will discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cardiac Resynchronization Therapy Defibrillators (CRTDs) sponsored by Boston Scientific. The sponsor is seeking expanded indications for the their CRTDs to include patients with low left ventricular ejection fraction (¡Ü30%) and wide QRS (¡Ý130 ms) who are NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I (ischemic etiology). On March 19, 2010, the committee will discuss, make recommendations and vote on a PMA for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI Pacing System is a pacemaker (with a standard pacing indication) that has been specifically designed to be safe for the MRI environment under certain MR scanning conditions.

Meeting Details:

On July 22, 2009, the committee will discuss, make recommendations, and vote on a Humanitarian Device Exemption (HDE) application, sponsored by Medtronic, Inc., for the MEDTRONIC MELODY Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE Transcatheter Valve Delivery System (NU10). The MEDTRONIC MELODY Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE Transcatheter Valve Delivery System (NU10) is indicated for use in patients with the following clinical conditions: Regurgitant (insufficient or leaky) Right Ventricular Outflow Tract (RVOT)The right ventricular outflow tract is that portion of the right ventricle leading up to the pulmonary valve and pulmonary artery. When the ventricles contract, blood moves along the outflow tract and through the pulmonary valve; blood then flows to the lungs where gas exchange takes place. ConduitsIn the context of this device, a surgically implanted tube that allows blood to pass from the heart to the pulmonary arteries.&sbull;Stenotic (stiff valve leaflets that cannot open or close properly) RVOT conduits where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting.&sbull;Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 millimeters (mm) in diameter when originally implanted. On July 23, 2009, from 8 a.m. to 10 a.m., and from 1 p.m. to 6 p.m., the committee will discuss general questions about adhesion barriers for cardiovascular use. Some of these questions will focus on understanding the target population (pediatric and/or adult) that would benefit from these devices and the development of appropriate endpoints for a clinical trial.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Atritech, Inc., for the WATCHMAN® Left Atrial Appendage (LAA) Closure Technology. The WATCHMAN® device, a percutaneously placed permanent implant, is intended as an alternative to warfarin therapy for patients with non-valvular atrial fibrillation. The WATCHMAN® LAA Closure Technology is designed to prevent embolization of thrombi that may form in the left atrial appendage thereby preventing the occurrence of ischemic stroke and systemic thromboembolism.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by TherOx, Inc., for the TherOx Aqueous Oxygen System (AO System). The system is intended for use in acute myocardial infarction (AMI) patients, who have undergone successful revascularization less than or equal to 6 hours from symptom onset. These patients were randomized to AO Therapy or not. The endpoint is reduction in the final size of the infarct. The system draws blood from the patient, hyperoxygenates it with the AO cartridge component of the system, and reinfuses the blood via the infusion catheter directly to the infarction site of the heart. This therapy is intended to be performed for 90 minutes post percutaneous coronary intervention/stenting.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Biosense Webster, Inc., a Johnson & Johnson Company, for the NaviStar ThermoCool irrigated RF ablation catheter. The device, an open-lumen, irrigated tip, steerable radiofrequency cardiac ablation catheter, is inserted through the venous circulation to the heart, across the intra-atrial septum to the left atrium to ablate cardiac tissue for the purposes of creating lines of block in the atria to eliminate conduction patterns that theoretically generate or allow propagation of paroxysmal atrial fibrillation.

Meeting Details:

Agenda: On November 29, 2007, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Abbott Vascular, for the XIENCE V Everolimus Eluting Coronary Stent System, which is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length = 28 millimeters (mm)) with reference vessel diameter of 2.5 mm to 4 mm. On November 30, 2007, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored. by Thoratec Corp., for the HeartMate I1 Left Ventricular Assist System (LVAS), which is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate I1 LVAS is intended for use both inside and outside the hospital.

Meeting Details:

On October 10, 2007, the committee will discuss; make recommendations; and vote on a premarket approval application, sponsored by Medtronic, Inc., for the Endeavor Zotarolimus-Eluting Coronary Stent System, which is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length < = 27 millimeters (mm) in native coronary arteries with reference vessel diameters of >= 2.5 mm to <= 3.5 mm. On October 11, 2007, the committee will discuss and make recommendations regarding clinical trial designs for carotid artery stenting in patients not at high risk for adverse events from surgical revascularization.

Meeting Details:

On September 19, 2007, the committee will discuss, make recommendations and vote on a premarket approval application, sponsored by SyntheMed, Inc., for the REPEL-CV, which is a surgical adjuvant indicated for reducing the incidence, severity and extent of post- operative adhesion formation in patients undergoing cardiac surgery. On September 20, 2007, the committee will discuss and make recommendations regarding clinical trial designs for cardiac ablation devices designed to treat patients with medically refractory atrial fibrillation.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by CryoCor Inc., for the CryoCor Cryoablation System, which is intended for the treatment of isthmusdependent atrial flutter in patients 18 years or older.

Meeting Details:

On March 1, 2007, the committee will discuss and make recommendations regarding the premarket approval application, sponsored by Medtronic Inc., for the Chronicle Implantable Hemodynamic Monitoring System. This implantable device is intended to reduce hospitalization events or equivalent events for worsening heart failure in patients with moderate to advanced heart failure. On March 2, 2007, the committee will discuss and make recommendations regarding clinical trial designs for Patent Foreman Ovale closure devices intended to prevent recurrent stroke.

Meeting Details:

The committee will discuss and make recommendations regarding issues related to stent thrombosis in coronary drug-eluting stents.

Meeting Details:

(Sponsor: Acorn Product: CorCap)On June 22, 2005, the committee will discuss, make recommendations, and vote on a premarket approval application for a cardiac device intended to treat patients with heart failure. (Sponsor: Abiomed Product: AbioCor)On June 23, 2005, the committee will discuss, make recommendations, and vote on a humanitarian device exemption for an artificial heart.

Meeting Details:

Sponsor of Meeting: Cardica Inc.’s device PAS-Port. But First the committee will hear a presentation by the Office of Surveillance and Biometrics outlining their responsibility for the review of postmarket study design. Then the committee will also hear an update on the status of recent devices brought before the committee. Finally the committee will discuss and make recommendations on a premarket notification submission for a coronary proximal anastomosis device(Cardica Inc.’s device PAS-Port).

Meeting Details:

The committee will discuss and make recommendations on CoolGardy catheter by Alsyius regarding a premarket notification submission for use in the induction, maintenance and reversal of mild hypothermia in the treatment of unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest when the initial rhythm was ventricular fibrillation.

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative. The committee will also discuss, make recommendations, and vote on a premarket approval application for a thoracic endoprosthesis intended for endovascular repair of the descending thoracic aorta.

Meeting Details:

The committee will discuss and make recommendations regarding clinical trial design in the evaluation of cardiopulmonary resuscitation enhancing devices/therapies for cardiac arrest patients.

Meeting Details:

On July 28, 2004, the committee will discuss, make recommendations, and vote on a premarket approval application supplement for a cardiac resynchronization device. On July 29, 2004, the committee will hear a presentation on Adverse Event Reports for Automatic External Defibrillators from 1996 – 2003. The committee will also discuss and make recommendations on a premarket notification (510(k)) submission for an Over-the-Counter Automated External Defibrillator.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a left ventricular assist system. The system is intended for use as a short or long term bridge to transplantation in cardiac transplant patients, and in patients with relative contraindication to transplantation who are expected to become transplant candidates with mechanical circulatory support, at risk of imminent death from nonreversible left ventricular failure. The device is indicated for use both inside and outside of the hospital.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a carotid stent indicated for use in the treatment of carotid artery disease in high-risk patients.

Meeting Details:

On March 17, 2004, the committee will discuss, make recommendations, and vote on a premarket approval application for a Total Artificial Heart indicated for bridge to transplant usage in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure and replacing the patient's native ventricles and valves. The device is intended for use inside the hospital. On March 18, 2004, FDA will present to the committee the history, current medical practice, and regulatory background regarding Aortic Anastomotic Devices. The committee will discuss and make recommendations regarding the type of data and study required to effectively evaluate performance of Aortic Anastomotic Devices for marketing, recognizing the significant public health impact on cardiac disease they represent.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a drug-eluting stent indicated for improving luminal diameter and reducing restenosis for the treatment of de novo lesions.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an excimer laser and laser catheters used for treatment of chronic critical limb ischemia (associated with Rutherford Categories 4, 5 and 6). The device is intended for use in patients with angiographically evident culprit stenoses and/or occlusions in the superficial femoral artery, popliteal and/or infrapopliteal arteries, who are poor surgical candidates and who are acceptable candidates for revascularization.

Meeting Details:

The committee will hear a presentation on post-market surveillance of diathermy interactions with implanted leads and implanted systems with leads. The committee will also discuss, make recommendations, and vote on a premarket approval application for an ablation catheter for treatment of atrial fibrillation in patients with drug refractory paroxysmal atrial fibrillation.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an endovascular graft and delivery system intended for treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysm.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a thermal (cold) cardiac ablation catheter and generator system intended for cryoablation of cardiac tissue to treat patients with atrioventricular tachycardia and for mapping of the atrioventricular node.

Meeting Details:

On October 22, 2002, the committee will discuss, make recommendations, and vote on a premarket approval application for a drug-coated coronary artery stent intended to treat coronary artery obstructions and to help prevent in-stent stenosis. On October 23, 2002, the committee will discuss and make recommendations on a premarket notification (510(k)) submission for an arterial cannula intended to prevent an adverse neurological or limb threatening event.

Meeting Details:

On September 9, 2002, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an endovascular graft placed percutaneously to treat infrarenal abdominal aortic aneurysms as an alternative to surgery. On September 10, 2002, the committee will discuss, make recommendations, and vote on a supplement to a PMA for a double disk occluder indicated for closure of patent foramen ovale in patients at risk for recurrent cryptogenic stroke or transient ischemic attack.

Meeting Details:

On March 4, 2002, the committee will discuss, make recommendations, and vote on a supplement to a premarket approval application (PMA) for a left ventricular assist device to be used as destination therapy in patients with end stage congestive heart failure. On March 5, 2002, the committee will discuss, make recommendations, and vote on a PMA for an implantable pacemaker/defibrillator used for treatment of both congestive heart failure and life threatening dysrhythmias.

Meeting Details:

No Webcasting for September 10, 2001, the committee will discuss, make recommendations, and vote on two premarket approval applications (PMA’s) for septal occluders. VIDEOTAPES ARE AVAILABLE!!!! On September 11, 2001, the committee will discuss, make recommendations, and vote on two PMA’s, one for a surgical sealant and one for a biological glue.

Meeting Details:

On July 9, 2001, the committee will hear brief presentations on issues related to endovascular grafting systems for the treatment of abdominal aortic aneurysms. The committee will then discuss, make recommendations, and vote on a premarket approval application (PMA) for a percutaneous myocardial revascularization system used in the treatment of angina. On July 10, 2001, the committee will discuss, make recommendations, and vote on two separate PMA’s for implantable cardiac devices used in the treatment of congestive heart failure. Background information for each day’s topic, including the agenda and questions for the committee, will be available to the public one business day before the meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the July 9 meeting will be posted on July 6, 2001; material for the July 10 meeting will be posted on July 9, 2001.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a peripheral stent used in the treatment of stenotic or occluded femoral or popliteal arteries. Subsequently, the committee will discuss clinical study design issues for peripheral stents used in the treatment of stenotic or occluded iliac arteries.

Meeting Details:

On February 5, 2001, the committee will discuss and make recommendations on a premarket submission for a distal protection device used in the treatment of saphenous vein graft disease. Subsequently, the committee is being asked to provide input to the agency regarding the design of clinical trials for distal protection devices.

Meeting Details:

On December 4, 2000, the committee will discuss and make recommendations on a reclassification petition proposing to down-classify Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters from Class III to Class II. --- Day 2 --- On December 5, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application for an implantable cardioverter defibrillator used in the treatment of atrial fibrillation.

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an intravascular radiation device used in the treatment of instent restenosis.

Meeting Details:

On June 19, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application for an intravascular radiation device used in the treatment of instent restenosis. On June 20, 2000, the committee will discuss a modification to the guidance document titled, "DRAFT Guidance for Implantable Cardioverter-Defibrillators". Specifically, the modification would allow general indications for use for implantable cardioverter defibrillators. The guidance document, version 4.3, was issued June 24, 1996.

Meeting Details:

Subsequently, the committee is being asked to provide input to the agency regarding the design of clinical trials for the following: 1) devices using spinal cord stimulation in the treatment of angina pectoris; 2) rate-responsive pacemakers, specifically the evaluation of rate-adaptive features; and 3) devices used in the treatment of atrial fibrillation. There will be a brief FDA presentation on the Least Burdensome provisions of the FDA Modernization Act of 1997.

Meeting Details:

On June 23, 1999, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an endovascular graft for the treatment of abdominal aortic aneurysms. Subsequently, the committee will discuss, make recommendations, and vote on a PMA for an endovascular graft for the treatment of abdominal aortic or aorto-iliac aneurysms. On June 24, 1999, the committee will discuss, make recommendations, and vote on a PMA for a prosthetic heart valve. Subsequently, the committee will discuss, make recommendations, and vote on a PMA for a dual-chamber defibrillator for the treatment of atrial and ventricular tachyarrhythmias. *** Call for Satellite, Videoconferencing and Webcasting ***

Meeting Details:

The committee will discuss and make recommendations on clinical trial requirements for future approval of coronary stents. An outline of the types of issues to be discussed by the committee can be found on the FDA website at http://www.fda.gov/cdrh/upadvmtg.html. Single copies of this outline are also available to the public by contacting the Division of Small Manufacturers Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, at 1-800-638-2041 or 301-443-6597.

Meeting Details:

The commmittee will discuss, make recommendations and vote on a premarket approval application for a transmyocardial revascularization device.

Meeting Details:

On July 21, 1998, the committee wil discuss, make recommendations, and vote on a premarket approval application (PMA) for a cardiac ablation devices for ventrcular tachcardia. On July 22, 1998, the committee is being asked to provide imput to the agency regarding the design of clinical trials to support PMA’s for cardiac ablation devices intended to treat atrial fibrilation and atrial flutter. Of particular concern are the following issues: (1) What are the appropriate controls to be used in such trials? (2) What are the appropriate safety and efficacy measures? and (3) When should assessments of these measures be made?

Meeting Details:

On June 29, the committee will discuss a premarket approval application for an external compression device used incardiopulmonary resuscitation. On June 30, the committee will discuss and make recommendations on permanent cardiovascular implants such as heart valves and vascular grafts.

Meeting Details:

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices. The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. The four subsets of blood lancets have been identified with the following indications for use: • Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and 3 • Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.

Meeting Details:

On June 27, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances. It consists of an extracorporeal blood system and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated carbon or resins, which may be coated or immobilized to prevent fine particles from entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. Sorbent hemoperfusion systems may also include the machine or instrument used to drive and manage blood and fluid flow within the extracorporeal circuit, as well as any accompanying controllers, monitors, or sensors. On April 4, 2013 (78 FR 20268), FDA issued a proposed order which, if made final, would reclassify sorbent hemoperfusion systems labeled for the treatment of poisoning and drug overdose class II subject to premarket notification [510(k)] and special controls, while sorbent hemoperfusion systems labeled for the treatment of hepatic coma and metabolic disturbances would remain class III requiring premarket approval (PMA) applications. The committee’s discussion will involve making recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of sorbent hemoperfusion devices labeled for the 3 treatment of poisoning and drug overdose. The regulatory history of sorbent hemoperfusion has been discussed as part of a previously published proposed rule (77 FR 9610). During session II on June 27, 2013, the committee will discuss and make recommendations regarding the proposed classification of implanted blood access devices for hemodialysis from class III to class II. The class III implanted blood access devices for hemodialysis include various flexible or rigid tubes, such as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic catheters that have a subcutaneous “cuff”' for tissue ingrowth. They are placed in a central vein to allow blood access. Chronic hemodialysis catheters serve as conduits for the removal of blood from the patient, delivery to a hemodialysis machine for filtering, and return of filtered blood to the patient. They have no moving parts, consisting, essentially, of flexible tubing terminating in rigid Luer lock connectors for attachment to a dialysis machine. Subcutaneous catheters are totally implanted below the skin surface with no external communication. Arteriovenous shunts and vessel tips are tubing with tapered tips that are inserted into the artery and vein. The tubing is attached to the roughened or etched outer surface of the tip. The tubing is external to the skin and can be accessed with needles. They are similar to subcutaneous catheters. On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which, if made final, would make the class III implanted blood access devices class II subject to premarket notification [510(k)] and special controls. The regulatory history of implanted blood access devices has been discussed as part of the proposed rule (77 FR 36951). The committee’s discussion will involve making recommendations regarding regulatory classification to either reaffirm class III or reclassify these devices into class II and comment on 4 whether special controls are adequate to reasonably ensure the safety and effectiveness of this device.

Meeting Details:

The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On July 10, 2013, the Agency plans to discuss the risk management of LOTRONEX (alosetron hydrochloride) tablets, by Prometheus Laboratories Inc., which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS-d). The Agency will seek the committee’s comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system.

Meeting Details:

On July 18, 2013, the committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at 3 minutes after administration of rocuronium.

Meeting Details:

Day 1: The committee will discuss the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis and the implications of using these criteria for drug approval. On July 23, 2013, during the morning session, the committee will discuss supplemental biologics license application (sBLA) 125057, HUMIRA (adalimumab) injection, by AbbVie Inc., for the proposed indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation by elevated C-reactive protein or magnetic resonance imaging, who have had an inadequate response to, or are intolerant to, a nonsteroidal anti-inflammatory drug. During the afternoon session, the committee will discuss sBLA 125160, certolizumab injection, by UCB, Inc., for the proposed indication of treatment of adult patients with active axial spondyloarthritis, including patients with ankylosing spondylitis.

Meeting Details:

On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is indicated for reconstruction of the intervertebral disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space. On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5- S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies.

Meeting Details:

On August 5, 2013, the committee will discuss new drug application (NDA) 204441, tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure).

Meeting Details:

On June 5 and 6, 2013, the committees will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline.

Meeting Details:

On May 22, 2013, the committee will discuss new drug application (NDA) 204569, for suvorexant tablets, submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance.