Archive for the 'Stents' Category

Medtronic unveils Endeavor Sprint drug eluting stent on a rapid exchange

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.

FDA nod to Bard’s Flair™ Endovascular Stent Graft

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.

FDA approves PMA supplement for Endologix’s Powerlink XL® System

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.

FDA approves market launch of Boston Scientific’s DES

The U.S. Food and Drug Administration has approved the commercialization of Boston Scientific Corporation’s TAXUS® Express2™ Atom™ Paclitaxel-Eluting Coronary Stent System. Designed for the treatment of small coronary vessels, the system is the first drug-eluting stent (DES) which has got the FDA approval for sale in the American market for use in vessels smaller than 2.25 mm in diameter.

Tryton launches Side Branch Stent System™ in Europe

Tryton Medical Inc., has launched its new Side Branch Stent System™ in Europe.
The novel stent system is designed to treat atherosclerotic lesions at the site of a bifurcation. The system will be available first in the Netherlands where TOP Medical has allied with Tryton for the distribution of the device. The Tryton Side Branch Stent System is an innovative technology that will solve the problems in the interventional treatment of patients suffering from complex coronary lesions, when used in combination with a conventional drug-eluting stent.

MIV Therapeutics provides VESTASYNC I trial’s update

MIV Therapeutics, developer of advanced drug-delivery systems for cardiovascular stents and next-generation coatings, has released updates on the progress of the VESTASYNC I trial. MIV’s VESTAsync™, a polymer-free drug-eluting stent, going through an year long clinical has ensured prevention of major adverse cardiac events in patients who have not taken anti-platelet medication ( plavix). The company has accumulated nine-month intravascular ultrasound (IVUS) and Quantitative Coronary Angiography (QCA) for all the fifteen people who have been enrolled in the VESTASYNC I trial.

MGuard coronary stent trial depicts positive efficacy and safety data

InspireMDInspireMD has achieved positive results with its MGuard coronary stent in an ongoing multicenter trial aimed at establishing the safety and efficacy of the product in high-risk patients with complex lesions. The study’s six-month data demonstrates no thrombosis and an overall MACE rate of 6.6%. The data also highlight the efficacy of MGuard in maintaining blood flow through the treated vessel after six months, according to the company. The product, which combines a coronary stent with an embolic protection device, has received a CE Marking to treat patients with coronary artery diseases.

XIENCE V Everolimus Eluting stent more effective than TAXUS Paclitaxel-Eluting stent

Abbott LogoA study published in the Journal of the American Medical Association (JAMA) indicated that the use of Abbott Laboratories‘ XIENCE™ V Everolimus Eluting Coronary Stent System in patients with coronary artery disease resulted in a 50% reduction in vessel renarrowing. It also showed an observed 42% reduction in major adverse cardiac events (MACE) at one year in the patients using XIENCE V Everolimus Eluting Coronary Stent System, as compared to the TAXUS® Paclitaxel-Eluting Coronary Stent System.

Carotid artery stenting as effective as surgery

A study published in the New England Journal of Medicine has shown that the use of carotid artery stenting to open severely blocked carotid arteries is as effective in protecting people from heart attack, stroke and death as surgery. The research was based on the three-year data from the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) study of Johnson & Johnson’s Precise nitinol stent and Angioguard guidewire.

Drug-coated stents could boost death rate in heart attack patients

Drug-coated stents increased the risk of death in certain heart attack patients by nearly five times according to a recent study presented at the meeting of the European Society of Cardiology in Vienna. “Patients are now very wary about these stents,” lead researcher Gabriel Steg said. “Personally, I don’t use these stents in heart attack patients any longer.”

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