Boston Scientific’s Promus Element Drug Eluting Stent was approved by FDA in late November and now the agency has demanded that the company includes a warning on its packaging about the risk of stent shrinkage.
Stents
Stenting Advisory Group Member Accused Of Overstenting
A malpractice lawyer is accusing Dr John Wang (Union Memorial Hospital, Baltimore, MD), a member of the committee tasked with stopping improper stenting in Maryland, of improper stenting in his own practice.
Abbott Trials Absorb™ Bioresorbable Vascular Scaffold Against Metallic Drug Eluting Stent
Abbott today announced the initiation of ABSORB II, the first randomized, controlled, multi-center clinical trial to evaluate the safety, efficacy and performance of the Absorb™ bioresorbable vascular scaffold (BVS) compared to the company’s XIENCE PRIME™ Everolimus Eluting Coronary Stent System.
First Patient In The Svelte DIRECT Drug-Eluting Stent Study
SvelteMedical Systems Announces Treatment of First Patient in the DIRECT Drug-Eluting Stent Study.
Boston Scientific Receives FDA Approval for PROMUS Element™ Plus Platinum Chromium Stent System
Boston Scientific has announced that it has received U.S. Food and Drug Administration (FDA) approval for the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System.
CE Mark For NeoVasc Reducer™ Product To Treat Refractory Angina
Neovasc Inc. has announced that it has received the CE mark designation for its Reducer™ product for the treatment of refractory angina.
BIOTRONIK Announces Six-Month Coronary Stenting ENERGY Registry Results
Biotronik’s thin strut PRO-Kinetic Energy bare metal stent with passive PROBIO coating showed excellent results in a 1,000 patient all-comers registry.
Stent Shrinkage Still In Spotlight. FDA Wades In.
FDA is taking a proactive stance and working with manufacturers to understand the issue of longitudinal compression in next generation Drug-Eluting Stents.
Jail for Cardiologist Who “Egregiously Violated The Trust Of His Patients”
A US doctor charged in an over-stenting scheme was handed an 8-year prison sentence and ordered to pay nearly $600,000 in restitution for defrauding Medicare and other health insurers.
Cryoplasty Post Dilatation Of SFA Decreases Risk Of Restenosis In Diabetics
Results from the COBRA clinical trial presented at TCT2011 show restenosis rate significantly reduced in diabetics when Cryoplasty adopted in SFA Stenting.
Transcatheter Cardiovascular Therapeutics conference 2011: Live link of UK case highlights FDA’s caution on Sapien Aortic Valve PMA.
Update from TCT2011 sourced from an article by Medical Device Daily
Medtronic Resolute® Drug-Eluting Stent Shows Strong Results, Even in Challenging Diabetes Patients with Coronary Disease
Pooled Data Analyses to Be Presented at TCT 2011 Demonstrate Heart Device’s Consistently Positive Performance Across Multiple Clinical Studies
Longitudinal Compression in Drug-Eluting Stents on the Agenda
Longitudinal Compression of Drug Eluting Stents with resultant potential shrinkage will be reviewed at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco next week
Abbott Receives U.S. FDA Approval for Next-Generation XIENCE PRIME™ Drug Eluting Stent
Following CE Mark approval in 2009, Abbott now gains FDA approval for Xience Prime Drug Eluting Stent
Medtronic Receives First FDA Approval of Cobalt Chromium Balloon-Expandable Stent to Treat Narrowed Iliac Arteries
Assurant® Cobalt Iliac Stent Features Novel Alloy and Modular Design; Company’s Peripheral Portfolio Augmented with Balloon-Expandable Option
BIOTRONIK Launches First 20 mm–200 mm Stents on 4 F Platform for Treatment of SFA and BTK Disease
New Pulsar-18 self-expanding stent system line extension now available from Biotronik