The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Shares of Edwards Lifesciences Corp. (NYSE:EW) continued to slide on Wall Street for the second straight day, despite positive earnings and a favorable FDA panel vote that should clear the way for the company to launch the Sapien transcatheter heart valve in the U.S.
Amid lawsuits concerning its Pinnacle metal-on-metal hip implant, Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics won U.S. Food & Drug Administration clearance for its next-generation Pinnacle ceramic-on-metal hip implant.
Ceramic-on-metal is a novel combination in the hip implant market, having undergone two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing as part of the clearance process.
Two studies show that gastric bypass surgery has better long-term results compared with sleeve gastrectomy and "lap-band" surgery.
The benefits of gastric bypass include greater weight loss, resolution of diabetes and improved quality of life, according to the two reports published in the February issue of Archives of Surgery.
MassDevice keeps a close eye on public medical device companies, tracking their quarterly sales and earnings reports. For the most recent filings, check out our Earnings Roundup, where we collect each quarter’s reports.
Here’s a quick rundown of a few releases over the past couple days:
Here’s a roundup of recent clinical trial and scientific study news:
Endologix Inc. (NSDQ:ELGX) closed its acquisition of Palo Alto, Calif.-based Nellix.
The all-stock deal, which Endologix announced Oct. 27, expands its aortic disorder treatment devices. The Irvine, Calif.-based company said the merger is designed to increase its share of the aortic repair market.
Endologix Inc. (NSDQ:ELGX) won CE Mark approval for its "expanded offering" of Powerlink stent graft products and PowerFit aortic extensions in the European Union.
The company may now begin marketing and selling 31 new sizes of its Powerlink stent grafts and 18 mm to 32 mm diameter models of the company’s PowerFit aortic extensions across the pond, allowing physicians to treat a wider patient population.
C.R. Bard Inc.’s (NYSE:BCR) peripheral vascular unit sued a pair of competitors over a patent covering its prosthetic vascular grafts made from expanded polytetrafluoroethylene.
The lawsuit, filed in the U.S. District Court for Arizona, accuses Endologix Inc. (NSDQ:ELGX) and Atrium Medical Corp. of infringing Bard’s patent for "Prosthetic Vascular Graft." Bard alleges that Atrium’s Advanta line of grafts and stents, its iVena vascular patch and Flixene graft violate the patent and that Endologix runs afoul with its Powerlink stent grafts.
A patent infringement lawsuit filed against Endologix Inc. (NSDQ:ELGX) by C.R. Bard Inc. (NYSE:BCR) isn’t stopping Endologix from pursuing opportunities to develop its expanded polytetrafluoroethylene stent graft technology.
Irvine, Calif.-based Endologix signed a deal to license a Canadian firm’s balloon expandable stent technology, saying it plans to integrate the technology into its Powerlink stent graft.
Endologix Inc. (NSDQ:ELGX) posted fourth-quarter sales of $13.7 million for the three months ended Dec. 31, 2009, up 27.9 percent compared with $10.7 million during the same period in 2008. Net losses narrowed 57.1 percent to $676,000, compared with $1.6 million during Q4 2008:
Provides 2010 revenue guidance of $62 to $66 million, an increase of 18% to 26%
