Cardiology Product Guide » stent

Medtronic Integrity Coronary Stent Gets FDA Approval

admin — Thu, 23 Sep 2010 06:35:31 +0000

The FDA has approved Medronic’s Integrity Coronary Stent System, based on an advanced biomedical engineering called continuous sinusoid technology, enabling the exploration of other new device concepts, such as a polymer-free drug-filled stent. The stent is said to feature a new, more flexible construction which is easier for surgeons to insert. A stent is a metal mesh which is placed inside an artery after it has been cleared of blockage.

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FDA okays expanded offering of Powerlink stent graft products

admin — Fri, 11 Jun 2010 18:19:53 +0000

Endologix Inc, a medical device maker, said it has received approval from the US regulatory authority to market an expanded offering of its Powerlink stent graft products. Powerlink, which is an already approved endovascular stent graft, is used in the treatment of abdominal aortic aneurysm. In abdominal aortic aneurysm, the aortic wall weakens, creating a “ballooning” of the blood vessel.

FDA Approves Marketing Clearance of the SoloPath™ TransFemoral Endovascular Access Catheter

admin — Tue, 17 Nov 2009 15:22:54 +0000

Onset Medical Corporation has announced that it has received U.S. FDA 510(k) marketing clearance for the Company’s SoloPath™ TransFemoral Endovascular Access Catheter. These catheters are designed to provide access to diseased arteries at a relatively small catheter size and then be expanded to provide a conduit for the delivery of larger diameter devices. Another clinical market for the SoloPath Catheter is in the delivery of stent grafts for the treating aortic aneurysms.

Boston Scientific receives FDA approval for stents

admin — Tue, 27 Oct 2009 05:24:32 +0000

Boston Scientific Corp has received approval from the FDA to market its new WallFlex Biliary RX covered stents. The stents are designed to treat clogged bile ducts in cancer patients. The liver excretes bile, which the body uses to help digest food. The WallFlex Biliary RX uncovered stent was cleared by the FDA in 2006. The new covered version of the stents was also approved by European regulators.

FDA approves Cordis Cypher drug-eluting stent

admin — Tue, 29 Sep 2009 06:16:24 +0000

The Johnson & Johnson subsidiary, Cordis, wins a nod from the FDA for its 2.25mm Cypher drug-eluting stent for treating blockages in small blood vessels. The company said data from the RESEARCH and T-SEARCH studies indicated that patients treated with the small Cypher model had a 65% lower incidence of death or heart attack than patients treated with the 2.25mm Boston Scientific device.

Boston receives FDA approval for Taxus Liberte

admin — Tue, 21 Jul 2009 18:20:41 +0000

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.

FDA approves Effient for thrombotic cardiovascular

admin — Tue, 14 Jul 2009 04:40:40 +0000

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.