A head-to-head comparison of Medtronic’s (NYSE:MDT) Resolute stent and Abbott’s (NYSE:ABT) market-leading Xience V DES showed "non-inferiority" between the two, according to results from the Twente study presented last week at the Transcatheter Cardiovascular Therapeutics symposium.
Biotronik
St. Jude CEO’s jibes at Medtronic, Med-tech weapon woes, Vaginal mesh and FDA reviews, Abbott’s split, Sunshine laws, Biotronik “sham recall” allegations and good news for heart valves made headlines this week | MassDevice.com +7
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
Biotronik weathers a blow in “sham recall” case against Johnson & Johnson
A New York State Supreme Court judge dealt a blow to Biotronik AG’s case against Johnson & Johnson (NYSE:JNJ) subsidiary Conor Medsystems over their defunct deal to distribute a drug-eluting stent.
Optos gains on Project Daytona FDA clearance | MassDevice.com Regulatory Roundup
Shares of Optos plc (LSE:OPTS) gained 6.4 percent after the company announced that the FDA granted 510(k) clearance in the U.S. for its Project Daytona retinal scanning device.
The British ophthalmology device maker’s stock closed at £1.62 today (about $2.64), up about 15 cents since August 25, the day before the clearance announcement, when OPTS shares closed at £1.52 ($2.49) on the London Stock Exchange.
Covidien logs first patient in Iliac stent studies | Research Roundup
Covidien Plc. (NYSE:COV) enrolled the first patients into its two Iliac stent trials, Durability and Visibility.
The trials will each enroll 75 patients at up 20 centers in Europe and the U.S. in order to test the safety and effectiveness of Mansfield, Mass.-based Covidien’s Iliac stent systems for patients with peripheral arterial disease.
Both studies have started in Belgium, enrolling patients at AZ St-Blasius in Dendermonde and Imelda Hospital in Bonheiden.
Biotronik: J&J ran “sham” recall | Legal Roundup
A Johnson & Johnson (NYSE:JNJ) subsidiary allegedly issued a sham recall of its drug-eluting CoStar coronary stent and spiked a distribution deal with Biotronik AG that cost the German medical device giant $100 million, according to a lawsuit filed in New York’s highest court.
Biotronik accuses J&J subsidiary of “sham” recall
A Johnson & Johnson (NYSE:JNJ) subsidiary allegedly issued a sham recall of its drug-eluting CoStar coronary stent and spiked a distribution deal with Biotronik AG that cost the German medical device giant $100 million, according to a lawsuit filed in New York’s highest court.
PLC ramps up for RenalGuard trials | Research roundup
PLC Systems Inc. (OTC:PLCSF) announced that it will commence its pivotal U.S. trial for the RenalGuard contrast-induced nephropathy treatment.
CIN is a form of acute renal failure caused by exposure to contrast media agents during image-guided cardiology and radiology procedures.
RenalGuard’s U.S. trials have been stalled for years, which PLC officials attributed to a troubled economy and stalled funding.
Cancer potential: Cell phones are “possible carcinogens”
MASSDEVICE ON CALL — A global research panel added cell phones to a list of possible cancer-causing agents after conducting a review of dozens of published studies on cell phone radiation.
The International Agency for Research on Cancer, an arm of the World Health Organization, classified cell phone radiation as "possibly carcinogenic," putting it in the same category as coffee and gasoline engine exhaust.
The verdict means that there is some evidence linking cell phones and cancer, but the scientific connection is too weak to draw solid conclusions.
Medtronic’s hospital GPO gamble
MASSDEVICE ON CALL — Medtronic Inc.’s (NYSE:MDT) decision to cut ties with group purchasing organizations could cost them in sales.
Fridley, Minn.-based Medtronic is watching rival players step in to fill the vacated contracts, including St. Jude Medical Inc. (NYSE:STJ) and Biotronik Inc., each of which announced Novation deals for heart-rhythm devices in April.
Stents: “Remarkable” results for MDT’s Resolute in patients with both diabetes and heart diseases | PCR 2011 Roundup
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.