Defibrillators news | Breaking defibrillators news

News

Advertisers:

FDA clears Guidant plant

...The restrictions were part of a warning letter issued by the FDA in the aftermath of recalls in 2005 of implantable cardiac Boston Scientific purchased Guidant almost exactly one year ago for $27.5 billion as Indianapolis-based Guidant still was working to resolve issues identified Advertisementby the FDA in the Dec.

22, 2005, warning letter.

At the time, analysts questioned the move.

The device problems had significantly reduced Guidant's market share and were spilling over to hurt other makers of implantable heart-rhythm devices.

Boston Scientific said at the time that it would focus more on resolving Guidant's issues with the FDA than on integrating the two companies.

Glenn Novarro, an analyst with Banc of America Securities, said the FDA action announced Monday should enable Boston Scientific to regain market share in the competitive business for implantable cardiac Fridley-based Medtronic and Little Canada-based St.

Jude Medical are the top competitors for Boston Scientific in the U.S.

market for both ICDs and pacemakers.

But there are still potential trouble spots for Boston Scientific, Novarro said in a note to investors, including a small ICD recall that the company announced this spring.

"In addition, the exodus of reps from (Boston Scientific's) sales force over the...