November 15, 2011 — A new clinical trial is testing the efficacy of rotational atherectomy (or rotablation, a process of drilling through plaque deposits) prior to implantation of a drug-eluting stent (DES). The trial found the process was not superior to standard balloon angioplasty and decreased the efficacy of the stent in reducing new tissue growth within the blood vessel.

November 14, 2011 – Boston Scientific welcomed positive outcomes from the COBRA clinical trial, which evaluated post-dilation of nitinol stents using CryoPlasty therapy with the PolarCath peripheral dilatation system compared to stenting with conventional balloon angioplasty in patients with diabetes presenting with blockages of the superficial femoral artery (SFA). The trial was funded through an unrestricted grant from Boston Scientific.

November 14, 2011 – OrbusNeich announced the introduction of the Combo dual therapy stent during a breakfast symposium chaired by Martin B. Leon, M.D., professor of medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York, at Transcatheter Cardiovascular Therapeutics (TCT) 2011 in San Francisco.

November 14, 2011 – The TWENTE clinical trial, which compared Resolute versus Xience V drug-eluting stents in a real-world population established non-inferiority between the two stents as measured by the primary endpoint: target vessel failure (TVF) at one year. Both stents also demonstrated low rates of stent thrombosis. Trial results were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

November 14, 2011 – The American Society of Echocardiography (ASE) reported that the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has recognized the value of contrast agents in echocardiography and made very positive revisions to the U.S. label for Definity, an ultrasound contrast agent produced by Lantheus Medical Imaging.

November 14, 2011 — Edwards Lifesciences Corp. announced data were presented on the quality of life impact and cost effectiveness of transcatheter aortic valve replacement (TAVR) were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The data focused on patients at high risk for traditional open-heart surgery. TCT was sponsored by the Cardiovascular Research Foundation.

November 11, 2011 – Boston Scientific reported results from the EVOLVE first human use trial demonstrating the non-inferiority of the Synergy everolimus-eluting stent system compared to the Promus Element everolimus-eluting stent system in treating de novo coronary artery lesions. The trial provided 30-day clinical and six-month angiographic primary endpoint data evaluating the safety and effectiveness of the bioabsorbable polymer-coated Synergy stent. Results were presented today during a late-breaking clinical session by professor Ian T. Meredith, M.B.B.S., Ph.D., director of MonashHeart, Monash Medical Centre, Melbourne, Australia, and principal investigator of the trial, at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.