Abbott (NYSE:ABT) enrolled its first patients in a Japanese trial of the Absorb bioresorbable vascular scaffold.
The Absorb stent opens clogged blood vessels and provides support to restore blood flow, and dissolves within about two years.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Abbott (NYSE:ABT) enrolled its first patients in a Japanese trial of the Absorb bioresorbable vascular scaffold.
The Absorb stent opens clogged blood vessels and provides support to restore blood flow, and dissolves within about two years.
MASSDEVICE ON CALL — Choosing bare metal stents over their drug-eluting cousins may decrease per-patient treatments costs by $401 without significantly increasing adverse health outcomes, according to a study published in the journal Circulation.
According to a registry of cardiovascular treatment, DES use decreased from 92 percent to 68 percent from 2004 to 2007, largely on concerns about possible risks. Despite the dramatic drop in use, incidence of target lesion revascularization increased only 1 percent (from 4.1 percent to 5.1 percent), and rates of death and MI didn’t change.
Medtronic Inc. (NYSE:MDT) said that its Resolute drug-eluting stent could level the playing field for cardiac patients suffering from diabetes in a study of nearly 1,000 patients.
The results of the pooled clinical trial are important because diabetic patients with heart disease generally have an increased risk of heart attack or other major cardiovascular event, and they’re targets for repeat procedures, according to Sigmund Silber of the Heart Catheterization Centre in Munich, Germany.
Abbott Laboratories (NYSE:ABT) is touting the results of a study of its bio-resorbable stent for the treatment of coronary artery disease.
Here’s the latest personnel changes from medical device, diagnostics and life science companies around the nation. For more recent hirings and firings, check out MassDevice’s compilation of the latest personnel moves.
Abbott Laboratories (NYSE:ABT) landed approval from European regulators for its drug-eluting bio-resorbable Absorb stent.
Reva Medical Inc. reeled in $84.8 million in an initial public offering in Australia.
The San Diego-based bioresorbable stent developer’s shares are slated to begin trading on the Australian Securities Exchange under the RVA symbol Dec. 23.
Reva issued about 7.7 million new shares of common stock at $1.10 Australian, according to the company.
There’s a “potentially troubling gap” in the Food & Drug Administration’s oversight of medical device clinical trials, according to the Wall Street Journal — the federal watchdog agency doesn’t inspect device-making plants during trials.
The Journal, citing the failed clinical trial of an Aptus Endosystems Inc. stent graft, said the lack of oversight means “hundreds of participants in clinical-trial studies of medical devices may be at risk of receiving faulty devices.”
Abbott today announced positive nine-month results from the first 45 patients enrolled in the second stage of the ABSORB trial. At nine months, Abbott’s bioresorbable vascular scaffold (BVS) demonstrated strong results that remained consistent with the six-month data from the same 45-patient group, with the rate of major adverse cardiac events (MACE) unchanged at 4.4 percent and no reports of blood clots (thromboses). These results were presented during the Cardiovascular Research Foundation’s 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.