Panel recommends Melody Transcatheter Pulmonary Valve
The FDA’s Circulatory System Devices Panel has unanimously recommended the approval of Humanitarian Device Exemption of Medtronic’s Melody Transcatheter Pulmonary Valve. The device is designed for patients with congenital heart defects, status post open heart surgery, who developed right ventricular outflow tract (RVOT) obstruction. The Melody Transcatheter Pulmonary Valve is the first transcatheter heart valve to be approved for commercial use anywhere in the world and the first to be reviewed by an FDA panel.

St. Jude Medical Inc has received approval from the US Food and Drug Administration (FDA) for a pair of wireless-ready pacemakers called the Accent RF pacemaker and Anthem RF CRT-P (for cardiac resynchronization therapy pacemakers). These pacemakers can wirelessly communicate with a programmer used by the clinician or a home monitor.

Boston Scientific has received the FDA approval to market its Taxus Liberte long paclitaxel-eluting coronary stent system, a next-generation drug-eluting stent designed for long lesions. At 38mm, Taxus Liberte long stent is the longest available drug-eluting stent (DES). This provides doctors with an option that can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs. The company plans to launch the product in the US in August.

Daiichi Sankyo Inc and Eli Lilly received approval from the US Food and Drug Administration (FDA) for Effient (prasugrel) tablets to be used for the reduction of thrombotic cardiovascular events. Effient reduces thrombotic cardiovascular events (including stent thrombosis) in patients suffering from acutecoronary syndromes and undergoing an artery-opening procedure known as percutaneous coronary intervention (PCI). PCI usually includes the placement of a stent to help keep the artery open.

The FDA has approved tadalafil, the active ingredient in the erectile dysfunction drug Cialis, to improve exercise ability in people with pulmonary arterial hypertension, which is a rare, life-threatening lung disorder. This disorder causes high blood pressure in lungs. Tadalafil, manufactured by the drug company Lilly, will be available in the U.S. as Adcirca in August by United Therapeutics Corporation.

Medtronic, Inc. has announced the U.S. market launch of the Sprinter Legend (semicompliant) and the NC Sprinter (noncompliant) balloon dilatation catheters on a rapid exchange delivery system. Recently approved by the U.S. Food and Drug Administration, the Sprinter Legend balloon catheter provides the latest innovations in balloon technology and is equipped to address difficult lesions in coronary angioplasty procedures. The Sprinter Legend balloon catheter features the lowest pre-dilatation profiles, making it suitable for use in challenging lesions, as well as allowing for the use of two balloons simultaneously in a small, guide catheter.

The U. S. Food and Drug Administration has granted approval to C. R. Bard, Inc. for marketing its Flair™ Endovascular Stent Graft with an optimized delivery system. The device consists of a self-expanding Nitinol stent encapsulated within the proprietary ePTFE graft material of Bard. The product has received the indication  for use in the treatment of stenoses in synthetic arteriovenous bypass grafts. A six-month long study conducted by Bard showed that the placement of the device resulted in more than twice the primary patency of balloon angioplasty. “The Flair Endovascular Stent Graft represents the first interventional technology demonstrating superiority to balloon angioplasty in maintenance of access patency.

The U.S. Food and Drug Administration has approved PMA supplement for Endologix, Inc.’s Powerlink XL® System that includes novel suprarenal stent grafts along with the Powerlink XL stent graft. The system used in the minimally invasive procedures to treat abdominal aortic aneurysms (AAA), now, has broadened indication. Endologix provides a choice to physicians for the optimal device for the treatment of various patient anatomies. This marks the entry of Endologix in a new market segment as 15% of endovascular AAA applications are for patients having aortic necks greater than 26 millimeters.

The U.S Food and Drug Administration (FDA) has given an unconditional Investigational Device Exemption to Berlin Heart Inc.’s EXCOR(R) Pediatric ventricular assist device (VAD).The device is a cardiac support system that is useful for pediatric patients who are critically ill and have been suffering from a severe heart failure. The system is a great support for patients waiting for a heart donor for transplantation.

The U.S. Food and Drug Administration has cleared Lumen Biomedical, Inc.’s LBI Embolectomy System to remove fresh, soft embolus and thrombus from vessels in the peripheral vasculature. The device consists of a 0.014″ guide wire that consists of a 3D fiber-based element used along with the Xtract Aspiration Catheter that had been cleared previously. It is based on the same technology that drives Lumen’s embolic protection system. The system will be helpful in the treatment of Peripheral Arterial Disease.