UPDATE: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device
October 9, 2014 by Brad Perriello
An FDA advisory panel offered a mixed view of Boston Scientific’s Watchman heart device today, concluding it is probably safe but not particularly effective in reducing the risk of stroke in patients with a certain type of irregular heart beat.
Despite the lack of likely effectiveness, the panel voted 6-5, with 1 abstention, that the benefits outweigh the risks, with some panelists saying it should be an option for patients. Read more
Medtronic launches Verify incontinence device in the U.S.
October 8, 2014 by Alexander Soule
Medtronic said yesterday that U.S. patients have begun receiving test evaluations with its new Verify system to evaluate whether they could benefit from its InterStim incontinence device.
The InterStim system is a neurostimulation device that delivers small amounts of electrical current to the sacral nerve in patients with overactive bladder, non-obstructive urinary retention or bowel incontinence who have not responded or are not candidates for more conservative treatments, according to a press release. Read more
FDA OKs Integra Lifesciences Puerto Rico plant
October 8, 2014 by Alexander Soule
Integra LifeSciences said the FDA determined its remediation efforts at a Puerto Rico manufacturing plant flagged with a warning letter last February have been effective.
The FDA issued a Form 483 after inspections in the fall of 2012, citing concerns about process validations, corrective and preventative actions, and document controls. Read more
FDA approves Bard's Lutonix DEB
October 10, 2014 by Brad Perriello
C.R. Bard said today that the FDA granted pre-market approval for its Lutonix drug-eluting balloon for treating peripheral artery disease, well ahead of the company’s expectation for approval early next year.
The Lutonix device is the 1st DEB to hit the U.S. market. It’s designed to dilate obstructions in the superficial femoral or popliteal arteries and leave behind a therapeutic dose of paclitaxel, a drug that’s also used to coat drug-eluting stents. Read more
