Category: Cardiac Assist Devices
World Heart Corp. says it's cutting 21 employees and ending clinical trials of its Levacor VAD program as it refocuses on an adult version of its PediaFlow ventricular assist device.
Officials at World Heart Corp. (NSDQ:WHRT) officially pulled the plug on clinical trials of the company's Levacor ventricular assist device (VAD) technology and laid off nearly half its workforce.
The FDA releases a new guidance recommending premarket approval applications be filed for implantable pacemaker pulse generators.
The FDA unveiled a new draft guidance today recommending that class III implantable pacemaker pulse generators be required to submit premarket approval applications or submit notice of completion of product development protocols.
"The Cardiovascular Devices Panel recommended that the implantable pacemaker pulse generator (which includes the internal pacemaker battery) be classified into class III because the device is implanted and life-supporting and presented a potential unreasonable risk of illness or injury," the guidance finds.
Arthrocare's shoulder repair suture system wins FDA clearance.
ArthroCare Corp. (NSDQ:ATRC) landed FDA clearance for its SpeedFix suture system for repairing tears in the shoulder joint, a common injury.
The sutures tout independent bone locking, suture tensioning and suture locking to fasten tissue to bone using double-loaded proprietary MagnumWire sutures.
The company won FDA clearance for their SpeedFix anchor system in November 2010.
Sunshine Heart sells 115 million shares at 4 cents each in a private placement offering that rounds up $4.6 million to fund an implantable ventricular assist device.
Cardiac medical device firm Sunshine Heart (ASX:SHC) raised $4.6 million by selling 115 million shares in a private placement with institutional investors in the U.S. and Canada at 4 cents per share.
The Eden Prairie, Minnesota-based company is developing the C-Pulse(R) Heart Assist System, an implantable, non-blood-contacting, heart assist therapy to treat moderate to severe heart failure.
American Therapeutic Corp. employees join company owners in pleading guilty to a Medicare mental-health clinic scam that billed the program $200 million over eight years, the largest racket of its kind in U.S. history.
MASSDEVICE ON CALL — Three Miami residents pleaded guilty to playing roles in the $200 million Medicare scam, the largest mental-health clinic con in U.S. history.
Joseph Valdes, 30, a marketer for the company, and James Edwards, 65, a recruiter, admitted to conspiracy to commit health care fraud and illegal kickbacks to patients.
A third defendant, Adriana Mejia, 40, pleaded guilty to money-laundering conspiracy.
Medtronic and St. Jude make important strides in the race to master neurostimulation for treatment of chronic pain, depression and high blood pressure.
MASSDEVICE ON CALL — St. Jude Medical Inc. (NYSE:STJ) and Medtronic Inc. (NYSE:MDT) logged some important wins in the neurostimluation arena this week, making progress on treatments for pain, depression and high blood pressure.
Share prices for Abiomed Inc. stock slipped today on news that the FDA warned the company about marketing a version of its Impella heart pump using un-approved claims.
Shares of Abiomed Inc. (NSDQ:ABMD) slipped nearly five percent on Wall Street this morning, after the FDA posted a warning letter admonishing the heart pump maker for marketing a device for uses it's not cleared for.
The federal watchdog agency said a May 12 review of Danvers, Mass.-based Abiomed's advertising, product labels and website "indicate that Abiomed is making claims that we stated were inappropriate in a January 28, 2010, letter to your firm" about its Impella Recover LP 2.5 cardiac assist device.