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Biosciences

Guidant Improves Transparency


Guidant, the medical device maker whose acquisition by Johnson & Johnson has been in trouble due to heart device recalls and other problems, moved to improve the company’s transparency Wednesday with the release of a detailed product performance report.

, the medical device maker whose acquisition by Johnson & Johnson has been in trouble due to heart device recalls and other problems, moved to improve the company’s transparency Wednesday with the release of a detailed product performance report.

“We understand that patients, physicians, and others are requesting additional information related to product performance,” said Fred McCoy, president, Cardiac Rhythm Management, Guidant.

In response, the Indianapolis-based company published a 153-page document that details the company’s heart devices, which include implantable defibrillators, pacemakers, and the small wires called leads that connect the devices to the heart.

The report also lists confirmed product failures, causes for failure patterns, and the options available to patients with faulty devices. Guidant stock was up $0.26 to $56.79 in recent trading.

Guidant’s recall problems surfaced in June when the company recalled some 29,000 of its defibrillators implanted in patients due to a design flaw that could cause the devices to short-circuit (see J&J Sticking to Guidant Deal and Guidant Warns on More Devices).

Recently, Guidant has been struggling to salvage its $25.4-billion acquisition by J&J. It sued J&J on Monday for failing to complete the acquisition of the troubled medical device maker (see Guidant Sues J&J Over Merger). J&J has hinted it can break off the deal due to Guidant’s product, saying recalls and related regulatory investigations are having “a material adverse effect on Guidant” (see J&J May Leave Guidant at Altar).

J&J May Leave Guidant at Altar

The slew of product recalls has put Guidant at the center of discussions on how the industry and federal government can improve disclosing when a medical device could malfunction or completely fail.

“I greatly support this concept of detailed disclosure and transparency,” said Eric Prystowsky, director of the clinical electrophysiology lab at Indianapolis-based St. VincentHospital. “It is where the entire industry needs to go.”

Mr. Prystowsky is a member of the Heart Rhythm Society Task Force currently drafting public policy recommendations to improve upon the post-market surveillance of heart device products.

Guidant has said there had been 43 reports of failure linked to two different models of its heart defibrillators. Two deaths were also connected to the failures.

Assessing Development Process

In September, Guidant announced the recall of two lines of its pacemakers (see Recall of Guidant Pacemakers). Also in September, reports surfaced that the U.S. Food and Drug Administration had brought in criminal investigators in its probe of Guidant’s recalls (see Guidant Handles Blows, So Far).

Furthering the company’s efforts to improve upon its own industry practices, Guidant said Tuesday it established an independent outside team of experts to assess the company’s new cardiac product development process. The team will focus on how Guidant can improve future product designs and development.

Dr. Dan Crippen, former director of the Congressional Budget Office, will head the team’s efforts.

The company also said Wednesday it will continue to pay a fourth-quarter dividend of $0.10 per share on common stock, as it did in the first three quarters of 2005.