Cardiology Product Guide

Clinical Update On TAMARIS Phase III Trial For NV1FGF

admin — Mon, 27 Sep 2010 15:27:24 +0000

Sanofi-aventis announced that the Phase III TAMARIS trial evaluating the investigational angiogenic therapy NV1FGF (riferminogen pecaplasmid) did not meet its primary endpoint. The primary endpoint was to demonstrate the superiority of NV1FGF vs. placebo in the prevention of major amputation or death from any cause over 12 months, whichever came first, in critical limb ischemia patients who were not eligible for revascularization.

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Angiotech Pharmaceuticals And Partner Athersys Announce Updated Results From Phase I Study Of Multistem(R) In Heart Attack Patients

admin — Mon, 27 Sep 2010 15:20:04 +0000

Angiotech Pharmaceuticals, Inc. and partner Athersys, Inc. announced updated results from its phase I clinical trial of MultiStem®, its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI), commonly referred to as a heart attack. The updated study results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference held in Washington, D.C. The results demonstrate that MultiStem was well tolerated at all dose levels and suggest improvement in heart function in patients.

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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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CardiAQ Valve Technologies To Present Latest In Vivo Results Of Its Transcatheter Mitral Valve Implantation System At TCT 2010

admin — Thu, 23 Sep 2010 06:09:46 +0000

Transcatheter heart valve company CardiAQ Valve Technologies (“CVT”) has announced that its Phase 1 porcine model study has clearly demonstrated the capability of its proprietary transcatheter delivery system to successfully and repeatedly deliver a mitral valve implant. The results of this significant research will be presented on Wed., Sept. 22, at the Transcatheter Cardiovascular Therapeutics (“TCT”) scientific meeting in Washington, D.C.

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CorMatrix Receives FDA IDE Approval To Begin Prospective, Randomized Evaluation Of New Onset Postoperative Atrial Fibrillation

admin — Mon, 13 Sep 2010 05:01:01 +0000

CorMatrix Cardiovascular, Inc. announced that FDA has granted conditional approval for the start of a multi-center, randomized clinical trial to demonstrate the safety of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation. Patients enrolled in the trial will undergo circumferential reconstruction of the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures and will be compared to subjects who do not undergo pericardial closure.

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

admin — Mon, 13 Sep 2010 04:54:22 +0000

Medtronic, 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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Celera Announces Issuance Of United States Patent Relating To LPA Gene Variant Associated With Increased Risk For Myocardial Infarction

admin — Tue, 07 Sep 2010 07:46:42 +0000

Celera Corporation announced that the United States Patent and Trademark Office has issued United States Patent 7,781,168 relating to methods of determining heart attack risk by detecting the Ile4399Met genetic polymorphism in the protease-like domain of LPA. Studies have shown this variant of the LPA gene is associated with a two-fold higher risk of major cardiovascular events (myocardial infarction, ischemic stroke and cardiovascular death)1-4.

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

admin — Tue, 07 Sep 2010 07:43:02 +0000

Boston 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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New NICE Guidance Will Improve Diagnosis And Treatment Of Chronic Heart Failure

admin — Mon, 30 Aug 2010 09:53:32 +0000

The National Institute for Health and Clinical Excellence (NICE) has issued its updated clinical guideline on the management of chronic heart failure in adults in primary and secondary care. In taking into account the wealth of new, high quality evidence that has been published since NICE’s original guideline in 2003, the new guideline provides the most comprehensive and up-to-date set of recommendations yet on the diagnosis, treatment, rehabilitation and monitoring of people with this condition.

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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

admin — Mon, 30 Aug 2010 09:49:20 +0000

Svelte™ 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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