The Food and Drug Administration has approved Medtronic Inc’s heart valve that can be implanted without open-heart surgery. Known as the Melody transcatheter pulmonary valve, the device is designed to be implanted through a small catheter inserted into the patient’s body. It replaces the pulmonary valve in patients born with a heart defect. It is the first heart valve approved for sale in the US that can be implanted without open-heart surgery.

The FDA has sent letters to physicians declaring a Class 1 recall of the Sutureless Connector intrathecal catheter made by Medtronic Inc. The device might be incorrectly labeled as compatible with the IsoMed Pump Model 8472, a drug pump Medtronic discontinued last year as part of what it calls a “planned product phase-out.” The catheter models 8709SC, 8731SC, 8578, and 8596SC are affected by the recall. Even though the catheter appears to fit the pump, the connection is not secure, which can cause drugs or cerebrospinal fluid to leak out, resulting in drug overdose, tissue damage and so-called spinal headaches.

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.

Medtronic has announced the U.S. launch of the Talent Abdominal Stent Graft on the Xcelerant Hydro Delivery System. EVAR is a treatment for aortic aneurysm, a bulge or weakening in the body’s main artery that can rupture with fatal consequences if left untreated. EVAR involves the navigation of a stent graft, via the body’s arteries, to the aorta. The stent graft is then deployed to create a tube within the aorta, reducing pressure on the aneurysm and the risk of rupture. EVAR is a minimally-invasive alternative to open surgical repair.

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.

Medtronic, Inc. has launched the Endeavor Sprint drug eluting stent (DES) on a rapid exchange (RX) delivery system in the U.S. The Endeavor Sprint system uses Sprinter ™ balloon catheter technology. The system puts the highly deliverable Endeavor DES on an enhanced delivery platform. This makes Medtronic’s flagship DES even easier for physicians to deliver to the site of coronary blockages. The Endeavor Sprint drug eluting stent system is the latest innovation to come out of our robust product pipeline in CardioVascular.

 Medtronic Inc. has received CE marking approval for the Defender embolic protection filter to be used during minimally invasive procedures in carotid arteries and saphenous vein grafts. The filter acts as a basket during the stenting procedure, allowing sufficient blood flow while trapping embolic debris. Without this protection, the debris can flow into other portions of blood vessels and lead to stroke.