Recently Approved Devices

Recently Approved Devices

The FDA has recently approved the following devices to be marketed.

Valiant Navion Thoracic Stent Graft System - P100040/S036 The Valiant Navion Thoracic Stent Graft System is an implantable stent graft (a fabric tube supported by a metal framework) intended to repair lesions in the descending thoracic aorta (large artery in the chest) through a small cut in the groin (area between the abdomen and thigh on either side of the body) without the need for a big cut in the chest. Some of these lesions include aneurysms, transections, and dissections.

GORE® Carotid Stent – P180010 The GORE® Carotid Stent is used to re-open narrowed regions of the carotid arteries in the neck which supply blood to the brain. The implant consists of a self-expanding stent mounted on a delivery catheter system. The stent is made of a nickel-titanium alloy (nitinol) tubing, laser-cut into a mesh shape, with an expanded polytetrafluoroethylene (ePTFE) lattice attached to its outer surface. The delivery catheter is a long, thin, tube-like device used to deliver the stent into the artery.

INCRAFT® AAA Stent Graft System - P150002 The INCRAFT® AAA Stent Graft System is a multi-component system that consists of permanent implantable flexible fabric tubes each supported by a metal framework (stent graft), and a long thin tube used to place the stent graft (delivery catheter). The device is used to repair a weakened and bulging section (aneurysm) of the aorta (largest artery in the abdomen) below the renal arteries (infrarenal abdominal aorta).

VASCADE® MVP Venous Vascular Closure System (VVCS) - P120016/S024 The VASCADE MVP VVCS is a system designed to close puncture sites in large vessels in the leg (femoral vein) following catheterization procedures. Catheterization procedures are commonly used to observe a disease or treat a disease/condition in blood vessels or in the heart. The system is comprised of a collagen patch and a long thin tube used to place the patch (delivery catheter).

Pipeline Flex Embolization Device - P100018/S015 The Pipeline Flex Embolization Device is a permanent mesh cylinder (stent) braided from platinum and tungsten and cobalt-chromium-nickel alloy wires intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform). The Pipeline Flex also includes a guidewire-based delivery system used to place the implant inside the patient.

Resolute Onyx Zotarolimus Eluting Coronary Stent System - P160043/S012 The Resolute Onyx Zotarolimus Eluting Coronary Stent System is a drug-coated device that contains two components: the stent and the catheter delivery system with a balloon that will inflate to deploy the stent. The stent is placed into a blood vessel (coronary artery) supplying blood to the heart and helps to keep the coronary artery open. The current approval expands the indications for use to include treatment of a blocked coronary artery (chronic total occlusion).

LIFEPAK® CR2 Defibrillator - P170018 Physio-Control's LIFEPAK® CR2 Defibrillator (including the QUICK-STEP Pacing/ECG Defibrillation Electrodes, the LIFEPAK CR2 Lithium Battery, and cprCOACH Feedback™ Technology) is a portable, battery operated, public access automatic external defibrillator (AED). The defibrillator is used to treat people experiencing sudden cardiac arrest (SCA) a medical condition in which the heart suddently and unexpectedly stops beating.

Woven EndoBridge (WEB) Aneurysm Embolization System - P170032 The Woven EndoBridge (WEB) Aneurysm Embolization System is a permanent nitinol (nickel titanium) self-expanding mesh ball implant for the treatment of wide-neck intracranial aneurysms located at or near branching areas of arteries in the brain. The device system consists of the implant, the delivery wire, and the controller that is used to detach the device from the delivery wire.

Zenith Dissection Endovascular System - P180001 The Zenith Dissection Endovascular System is a flexible, metal tube covered with fabric (stent graft) with an optional bare stent (flexible, metal tube that is not covered with fabric) that are supplied on separate long, thin, tube-like devices (delivery catheters). The Zenith Dissection Endovascular System is intended for the treatment of patients who have a tear (dissection) in the inside lining of the large artery in their chest (descending thoracic aorta), which allows blood to flow between the layers of the aortic wall, causing separation of these layers.

Spiration Valve® System - P180007 The Spiration Valve System is an implantable bronchial valve and delivery system used to reduce over inflation of the lungs due to severe emphysema in adults. The umbrella shaped one -way valve is placed in the targeted airway using a minimally invasive procedure. The valve is comprised of a flexible nickel-titanium (Nitinol) frame that supports a polymer membrane, with anchors to hold the valve in place. The Spiration Valve is designed to be a permanent implant, but can be removed if necessary using the removal rod.