Archive for the 'Stents' Category

Medtronic Integrity Coronary Stent Gets FDA Approval

MedtronicThe 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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Medtronic Announces First European Implant Of New Drug-Eluting Stent At Southampton General Hospital, UK

MedtronicMedtronic, Inc. has announced the CE (Conformité Européene) mark and international launch of the Resolute Integrity Stent System for the treatment of coronary artery disease, a leading cause of death and poor quality of life. The Resolute Integrity Stent System features a novel drug-eluting coronary stent with superior deliverability the ability of the device to traverse the patient’s vasculature and reach the blockage in the heart artery.

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Clinical Trial Enrollment For SYNERGY(TM) Coronary Stent With Bioabsorbable Polymer And Everolimus Drug Coating EVOLVE

Boston Scientific CorporationBoston Scientific Corporation has announced the start of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its fourth-generation SYNERGY™ Coronary Stent. The SYNERGY Stent uses a bioabsorbable PLGA polymer and everolimus drug formulation to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs into the body, leaving behind only a bare-metal stent.

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Svelte(TM) Medical Systems, Inc. Receives CE Mark Approval To Market The Svelte Acrobat Stent-On-A-Wire (SOAW) Coronary Stent System

Svelte Medical SystemsSvelte™ Medical Systems, Inc. has announced that it has officially received the CE Mark to market its Acrobat  Stent-on-a-Wire (SOAW) Bare Metal Coronary Stent System in the European Union. The Acrobat  SOAW stenting system has been shown in clinical trials to facilitate direct stenting and has the potential to provide substantial procedural time and cost savings. These savings are realized by eliminating the need for a coronary guidewire and balloon dilatation catheters.

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Boston Scientific Begins Clinical Trial Enrollment For New Coronary Stent With Bioabsorbable Polymer And Everolimus Drug Coating

Boston Scientific CorporationBoston Scientific Corporation has announced the start of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its fourth-generation SYNERGY™ Coronary Stent. The SYNERGY Stent uses a bioabsorbable PLGA polymer and everolimus drug formulation to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs into the body, leaving behind only a bare-metal stent.

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FDA Approves Expansion of Endologix’s Main Product Line

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

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

Boston ScientificBoston 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.

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

cypher stentSORT 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.

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“Nanoburrs” To Clear Arteries, Fight Heart Disease

Massachusetts Institute of Technology“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.

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