Jan. 5, 2007 — MedicalCV, Inc., a cardiovascular surgery company, says it will amend its 510(k) submission for clearance of its SOLAR automated surgical ablation system for soft tissue ablation only following discussions with FDA and the company’s own counsel. Once clearance is obtained — which is expected imminently — Medical CV plan to market the system immediately.

Jan. 5, 2007 — An announcement from AstraZeneca is expected soon about the company’s experimental heart drug AGI-1067, the company’s partner AtheroGenics Inc. hopes to present results from a pivotal Phase III clinical trial to the American College of Cardiology (ACC) meeting in New Orleans.

Jan. 5, 2007 — A French court has ruled that Abbott Laboratories’ Xience V drug-eluting coronary stents infringe patents that are under exclusive worldwide license to Medtronic from evYsio Medical Devices ULC.

AFX News Limited reports that the Tribunal de Grande Instance de Paris ruled that Abbott's Xience V DES infringes evYsio's European Patent No. EP-B- 0 888 093 and has awarded evYsio the right to enjoin the importation, offering for sale, or sale of the Xience V stent in France.

Jan. 5, 2007 — A report in the January issue of the Journal of the American College of Cardiology finds that as many as a third of Americans who get implantable defibrillators might not need them. The University of Michigan Medical Center study says that as much as $690 million could be saved in Medicare spending for the devices.

AP reports that a Dec. 27 Medicare proposal may could double the number of hospitals authorized to implant the HeartMate mechanical heart device made by Thoratec, the only company with a U.S.-approved device to treat heart failure patients who are not eligible for heart transplant because they have a life expectancy under two years.

Non-white, low-income patients without commercial insurance are more likely to delay diagnosis of peripheral vascular disease (PVD), which often results in amputation of the lower limb(s) according to a study published in the January 2007 issue of the Journal of Vascular Surgery. In addition to the immense psychological tool of limb loss, financial impact of the care of the amputees is estimated to be more than $4 billion annually.

HMS Technologies, Inc. (HMS), the exclusive federal distributor for the commercial versions of the EZ-IO Emergency Vascular Access products by Vidacare Corp., has received a medical device GSA Federal Supply Schedule (FSS) for the EZ-IO product system. The EZ-IO product system provides an immediate, safe and secure method of accessing the circulation through the intraosseous (IO) route, a, AHA-recommended technique that is being used by an increasing number of emergency care personnel for resuscitation and stabilization.

Dual-chamber pacing coupled with Boston Scientific's AV Search Hysteresis (AVSH) programming has the potential to reduce heart failure hospitalization and all cause mortality for patients at risk for sudden cardiac death according to results of the INTRINSIC RV trial, which were published this week in the January issue of the journal Circulation.

Heartwire cites results of a new study finding that current heart-failure performance measures, with the exception of the prescription of an ACE inhibitor or angiotensin receptor blocker (ARB) at discharge, have little relationship to patient mortality or combined mortality/rehospitalization in the first 60 to 90 days after discharge.

And though not one of the measures of performance, the prescription of beta blockers at discharge was associated with the most significant improvement in heart-failure outcomes.

A review by physicians at Tulane University School of Public Health and Tropical Medicine shows that Vitamin B12 supplements are not effective in preventing strokes, heart attacks or death in people with a history of vascular disease. A New York Times article reports that Vitamin B12 reduces the blood levels of homocysteine, a risk factor for cardiovascular disease, but the reduction apparently has no effect on survival.

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