Presentation about Litigation on Stent Markets (2003 year)

PPT file

Cordis Corporation, a Johnson & Johnson company, announced that U.S. District Judge Sue Robinson 27 March upheld two March 2005 jury verdicts that Cordis’ pioneering patents for balloon expandable stents were valid and infringed by Boston Scientific Corporation and Medtronic, Inc. stents.

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Medtronic, Inc. today announced that it has received U.S. Food and Drug Administration approval of the AneuRx® AAAdvantage™ abdominal aortic aneurysm (AAA) stent graft with Xcelerant® delivery system. AneuRx AAAdvantage is a next-generation, minimally-invasive device that treats dangerous bulges in the aorta, the body’s largest artery, that can rupture without warning.

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Restenosis within bare-metal stents is often treated with repeat percutaneous coronary intervention, although subsequent recurrence rates are high, with vascular brachytherapy (VBT) affording the best results. The effectiveness of drug-eluting stents in this setting has not been established. OBJECTIVE: To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in patients with restenotic lesions after prior stent implantation in native coronary arteries.

Abstarct

The new device, which is approved for both diagnostic and interventional procedures, gives physicians an improved method for sealing arterial catheterization access sites. Because the new device provides more coverage on the artery surface than previous devices, physicians may more effectively achieve hemostasis (cessation of bleeding), even in patients using certain blood thinners. In addition, the device’s coated suture makes it easier to use, enhancing physicians’ ability to effectively seal access sites. If physicians need to access the site a second time, they can safely re-enter with the Angio-Seal VIP device within 1 centimeter of the original site.

More about device

via Medgadget

Case Report. Authors describe a new stenting technique for the so-called true bifurcation lesions.

Medline link

Although vascular brachytherapy is the only approved therapy for restenosis following bare-metal stent implantation, drug-eluting stents are now being used. Data on the relative merits of each are limited. OBJECTIVE: To determine the safety and efficacy of the sirolimus-eluting stent compared with vascular brachytherapy for the treatment of patients with restenosis within a bare-metal stent. DESIGN, SETTING, AND PATIENTS: Prospective, multicenter, randomized trial of 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community medical centers. Data presented represent all follow-up as of June 30, 2005.

Pubmed abstract

Two U.S. studies now find that inserting a new, drug-coated stent inside the old one—like a sleeve inside a sleeve—keeps blood flowing better than zapping it with radiation does.

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Previous research has shown that adding the antithrombotic drug abciximab, (a glycoprotein IIb/IIIa receptor inhibitor) to therapy with ticlopidine plus aspirin significantly reduces post-stent implantation complications, including death, repeat heart attack or reintervention. The drug ticlopidine has been replaced by clopidogrel in recent research, which is safe and acts more rapidly in a 600 mg dosage level, offering better platelet inhibition within two hours of administration.

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The StarClose™ Vascular Closure System (VCS) is used to close a puncture site in the femoral artery and stop bleeding following a 5 or 6 French diagnostic cardiac catheterization procedure. After a cardiac catheterization procedure it is necessary to stop the bleeding in a blood vessel in the leg (the femoral artery). The StarClose™ VCS uses a nitinol clip to stop bleeding by closing the hole in the artery.

FDA device approval page

To assess the outcome of stenting in patients with severe left ventricular dysfunction, 149 consecutive patients undergoing coronary stenting with an ejection fraction less than or equal to 40% (mean 35 +/- 10%) were analyzed. Angiographic and clinical success were achieved in all patients.

Abstract

In order to study the possible association of clinical risk factors on the incidence of restenosis; clinical predictors were determined in 98 patients (81 males and 17 females) who all undergone follow-up coronary angiography within 8.2 months after PCI.

Abstract

Boston Scientific has submitted to the FDA the final module of the company’s pre-market approval application for its Taxus Liberte paclitaxel-eluting coronary stent system.

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To assess the long-term patency and clinical success of subintimal angioplasty in patients with limb-threatening ischemia. METHODS: From 1999 through 2004, 29 patients with superficial femoral artery (SFA) or popliteal artery occlusion and rest pain or tissue loss underwent subintimal angioplasty. Patients had subintimal wire placement followed by percutaneous transluminal angioplasty and stent placement.

PubMed abstract

Guidant Corporation (NYSE: GDT) March, 9 announced enrollment of the first patient in a first-in-man clinical trial designed to evaluate the safety of a fully bioabsorbable everolimus eluting stent platform for the treatment of coronary artery disease. The trial, called ABSORB, will enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands.

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