Cardiology Product Guide » Stents

FDA Approves Expansion of Endologix’s Main Product Line

Jim Marino — Wed, 07 Jul 2010 18:40:52 +0000

Endologix Inc said that the Food and Drug Administration has approved the expansion of its main product line. The FDA approval covers 31 new sizes of its Powerlink stents, which it said should expand the number of patients they can be used on by to 5% to 10%. Endologix’s stents are used to reinforce a ruptured or ballooning section of an artery.

FDA okays expanded offering of Powerlink stent graft products

Jim Marino — 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.

Boston Scientific Launches Platinum Chromium TAXUS(R) Element(TM) Stent System

Jim Marino — Fri, 11 Jun 2010 09:08:28 +0000

Boston Scientific Corporation has announced the market launch and first implants of its TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The TAXUS Element Stent System is the Company’s third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It received CE Mark approval last month, which included an indication for the treatment of diabetic patients.

Read the full story here

Cypher(R) Stent Beats Endeavor(R) in Recent Trial

Jim Marino — Wed, 24 Mar 2010 20:34:40 +0000

SORT OUT III Data Presented at American College of Cardiology reported the long-term follow-up of the largest randomized comparison between the CYPHER(R) Sirolimus-eluting Coronary Stent and Medtronic’s Endeavor(R) Stent highlighting significant and sustained clinical differences.

The findings report that the CYPHER(R) Stent was associated with significantly lower rates of death, myocardial infarction, and repeat procedures than the Endeavor(R) Stent out to 18 months. This information was also published in the Lancet Journal.

To read the full story, click here.

“Nanoburrs” To Clear Arteries, Fight Heart Disease

Jim Marino — Thu, 21 Jan 2010 07:33:13 +0000

“Nanoburrs” are nanoparticles coated with a sticky protein that makes them cling onto artery walls while they slowly release drugs: the US researchers who are developing them hope they will one day provide an alternative to drug-releasing stents in fighting heart disease. The Massachusetts Institute of Technology, (MIT) and Harvard Medical School researchers, wrote about how they developed and tested the nanoburrs as potential drug-releasing agents for targeting and repairing damaged blood vessels.

For the full stroy, Click Here

Abbott’s XIENCE V(R) Approved In Japan – Second Largest Drug Eluting Stent Market Worldwide

Jim Marino — Tue, 12 Jan 2010 06:09:37 +0000

Abbott announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V (R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. Japan is the second largest drug eluting stent market in the world after the United States, with approximately 200,000 stent procedures performed each year. The company plans to launch XIENCE V in Japan in the upcoming weeks, immediately following final reimbursement authorization.

For the full story, Click Here

Boston Scientific Announces European Approval and Launch of Platinum Chromium PROMUS(R) Element(TM) Stent System

Jim Marino — Tue, 01 Dec 2009 13:04:09 +0000

Boston Scientific Corporation has announced that it has received CE Mark for its PROMUS® Element(TM) Everolimus-Eluting Coronary Stent System, the Company’s third-generation drug-eluting stent (DES) technology. The PROMUS Element system incorporates a unique platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. The Company will begin marketing the PROMUS Element system immediately in the European Union and other CE Mark countries.

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

Jim Marino — 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

Jim Marino — 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

Jim Marino — 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.