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.
Structural Heart
Pacemakers taken from the dead give new life to heart patients in India | MassDevice.com On Call
MASSDEVICE ON CALL — Pacemakers taken from funeral homes in the U.S. have been sent to India and successfully implanted in new patients thanks to researchers from the University of Texas Health Science Center.
Their research proved that used pacemakers can be refurbished and turned over to patients who could not afford a new device.
Wall Street reacts to ABT’s spinout plan, Genetic Technologies settles patent spat, Medtronic’s ED stent works when drugs fail | MassDevice.com +3
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three biggest and most influential stories from the day’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 today, make sure you’re still in the know with MassDevice +3.
Erectile dysfunction: Medtronic’s ED stent proves successful when drugs fail
Men with erectile dysfunction may be able to turn to Medtronic Inc.’s (NYSE:MDT) drug-eluting pudendal stent when drugs fail to help, according to a preliminary study.
The Minneapolis-based medical device giant concluded an initial feasibility study of 30 men, and 30-day results found the drug-eluting stent safe and significantly effective in treating erectile dysfunction.
Medtronic’s and Edwards’ valves fare well in two year study, but Sapien is still two years ahead in the U.S.
Edwards CEO: We expect FDA to OK Sapien “any day now”
Edwards Lifesciences (NYSE:EW) expects the FDA to approve its Sapien heart valve “any day now,” according to CEO Michael Mussallem.
Edwards has been hanging fire since July, when an FDA advisory panel recommended that the federal watchdog agency approve the Sapien device, which is a transcatheter aortic valve replacement.
Yesterday Mussallem told analysts on a conference call that Edwards believes it’s “at the end of the line” for approval.
Edwards’ Q3 sales rise 18 percent, profits jump 8 percent | Earnings Roundup
Edwards Lifesciences (NYSE:EW) can’t seem to get a break on Wall Street, where its share price slipped 3.4 percent today despite growth for its top and bottom lines.
The Irvine, Calif.-based heart valve maker missed The Street’s earnings forecast by a mere penny, but that was enough to send its shares down to a $67.79 close.
St. Jude, Boston Scientific log clinical milestones
Edwards loses nearly 5 percent on FDA rumor
Shares of Edwards Lifesciences (NYSE:EW) bounced back today after losing nearly 5 percent yesterday on speculation that FDA approval of its next-generation Sapien heart valve could be delayed.
Edwards shares closed at $68.53 yesterday, down 4.8 percent from its $72 close the day before. EW shares were trading at $69.73 as of about 1:15 today, up nearly 1.8 percent.
Stents: Cook Medical’s Evolution lands FDA clearance
Cook Medical landed 510(k) clearance from the FDA for its Evolution duodenal controlled-release stent for the treatment of malignant gastric outlet obstruction.
Meant for use in patients with pancreatic or GI-related cancers, the stent offers relief of abdominal pain, vomiting, malnutrition and aspiration associated with obstructions in the intestinal tract.
New Stent Provides Relief to Patients with Advanced Small Intestine Cancer
WINSTON-SALEM, N.C.–(BUSINESS WIRE)–Cook Medical announced today that its Evolution® Duodenal Controlled-Release Stent was recently granted 510(k) clearance by the Food & Drug Administration (FDA). This new stent expands palliative care options for patients experiencing issues associated with malignant gastric outlet obstruction (GOO), a late stage complication of a variety of GI related cancers with pancreatic cancer being the most common cause.1 Studies indicate that as many as 50 percent of the malignancies involving the small intestine, including pancreatic, gastric, duodenal and cholangiocarcinoma, occur in the duodenum,1 the part of the small intestine connected to the stomach.