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.
USA
Early Clinical Evaluation Of Medical Devices In USA: FDA Issues Draft Guidance Document
Draft Guidance for Industry and Food and Drug Administration Staff – Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
Stryker Plans To Axe 5% Of Workforce And Make $100Million Annual Productivity Gain
Stryker has announced its intention to implement focused workforce reductions of approximately 5% of its global workforce and other restructuring activities that are anticipated to reduce annual pre-tax operating costs by over $100 million beginning in 2013.
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.
Patients Who Use Narcotics Prior To Knee Replacement Experience Worse Results
Patients who are dependent on opioids for pain management before knee replacement surgery have much more difficulty recovering, a study recently published in theJournal of Bone and Joint Surgery (JBJS) has found.
More from TCT2011: Transfemoral, but not transapical TAVR, “economically attractive”
Researchers claim Transapical TAVR is “unattractive from a health economic perspective.” compared with femoral approach.
“Bridging” Stent Patients to Cardiac Surgery
Late breaking clinical trial results from testing of cangrelor, an investigational intravenous antiplatelet, showed patients can be “bridged” from the time that their physicians stop their oral antiplatelet drugs until they undergo cardiac surgery.
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
Despite Higher Sales, Atricure 3rd Quarter Loss Increased as Margins Decrease and Operational Costs Climb
Atricure’s Quarterly Earnings Report gives reason for optimism despite increased losses.
Cordis Empira PTCA Catheters get 510(k) approval for Coronary Artery Disease
Cordis Corporation has announced EMPIRA™ and EMPIRA™ NC RX PTCA Dilatation Catheters have received 510(k) regulatory clearance for the treatment of coronary artery disease.
Mobile surgery trailer shows hospital staff new techniques
Physicians and nurses from a US hospital experience Covidien’s high-tech trailer displaying minimally invasive surgical instruments and techniques.
E-Nose ‘TB sniffer’ offers hope of early diagnosis
Indian researchers say they are close to developing an “electronic nose” to sniff out tuberculosis on the breath.
FDA Reports Growth in Medical Device Adverse Events
Medtech Business reports FDA’s observations that growth in reported serious adverse events has outpaced revenue growth by 8% each year in the past decade.
Integra Showcases New Headlight System at NASS
Integra LifeSciences Holdings Corp. featured the new Integra(TM) LED Headlight System at the North American Spine Society (NASS) Annual Meeting in Chicago, Illinois, November 2-5, 2011.
NASS 2011 held in Chicago this week.
This week has seen the 26th meeting of the North American Spins Society Meeting in Chicago.
Edwards Lifesciences Receives FDA Approval for First Catheter-Based Aortic Heart Valve in the U.S.
Edwards Lifesciences gains first U.S. commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.