The PARTNER Trial Cohort B results demonstrate widening survival benefit for transcatheter aortic valve implantation (TAVI) patients at two years, with mortality for TAVI at 43.4% compared to 67.6% for medical therapy. Median days alive outside hospital were 699 days for TAVI patients and 355 days for standard therapy patients, a difference of around one year.
Paul S Teirstein, Scripps Clinic La Jolla, California, USA, presented positive clinical endpoint data from the PLATINUM Long Lesion trial at the Cardiovascular Research Foundation’s annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (San Francisco, USA, 7−11 November 2011).
Boston Scientific reported positive long-term data from the PERSEUS clinical programme, which demonstrated favorable two-year safety and effectiveness outcomes for the ION (TAXUS Element) Paclitaxel-Eluting Platinum Chromium stent system used in coronary artery disease versus prior-generation paclitaxeleluting stents.
Edwards Lifesciences has received approval from the FDA for the transfemoral delivery of the Edwards Sapien transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis. This is the first US commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.
Royal Sussex County Hospital, Brighton, UK, has enrolled the first patient in the United Kingdom for the Gore REDUCE clinical study of patent foramen ovale closure. David Hildick-Smith, director of Cardiac Research Unit, Brighton and Sussex University Hospitals and study investigator, performed the first procedure.
Aptus Endosystems, a medical device company developing advanced technology for treating abdominal aortic aneurysms (AAA), announced the appointment of James R Tobin to its board of directors. Tobin headed Boston Scientific for 10 years and was responsible for that company’s significant growth during that period.
Boston Scientific has started patient enrolment in the OMEGA clinical trial, designed to evaluate the safety and effectiveness of its Omega platinum chromium bare-metal coronary stent system in treating patients with a single coronary artery lesion.
On 4 October, Abbott announced it has begun US patients’ enrolment in the EXCEL (Evaluation of Xience Prime or Xience V versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial
JenaValve Technology has announced that the company has received CE mark approval for its transapical transcatheter aortic valve implantation (TAVI) system of the second generation.
Draft guidance from NICE’s Diagnostics Assessment Programme on four new generation cardiac computed tomography (CT) scanners has been issued for public consultation. The provisional recommendations support the use of Somatom Definition Flash CT scanner (Siemens AG Healthcare), Aquilion ONE (Toshiba Medical Systems), Brilliance iCT (Philips Healthcare) and Discovery CT750 (GE Healthcare) in the NHS in England for people with suspected or known coronary artery disease in whom imaging is difficult with earlier generation CT scanners.
A fully biodegradable stent was safe over the course of a decade-long study, researchers reported. In a single-institution study, major complication rates among 50 patients treated with Igaki-Tamai stents were similar to those seen with metal stents, according to Kunihiko Kosuga, MD, PhD, of Shiga Medical Center for Adults in Moriyama City, Japan, and colleagues.
The Resolute drug-eluting stent (Medtronic) yields strong performance in coronary artery disease (CAD) patients both with and without diabetes through two years of follow-up, according to results from the RESOLUTE clinical study presented by Scott W Lee, Los Angeles, USA, at a late-breaking clinical trials session at the American Association of Clinical Endocrinologists (AACE) 21stAnnual Meeting & Clinical Congress (23–27 May, Philadelphia, USA).
St Jude Medical has announced results of the FAME II trial demonstrating that patients with fractional flow reserve (FFR)-guided stenting plus the best available medical therapy had superior outcomes to those treated with medical therapy alone. Results published online in the New England Journal of Medicine (NEJM) and presented during a Hot Line session at the ESC (European Society of Cardiology) Congress 2012 revealed that use of the PressureWire (technology used to measure blood flow restriction in the coronary arteries) yielded an 86% relative risk reduction for unplanned re-admission to the hospital with urgent revascularisation in patients with stable coronary artery disease.
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