The cardiovascular sector grabbed the bulk of headlines over the past month, making news even when it was trying to avoid doing so.

Abiomed (Danvers, Massachusetts) was forced to break its silence concerning the first implantation of its AbioCor total artificial heart at Jewish Hospital (Louisville, Kentucky), following a news leak to that city's Courier-Journal. The implantation was made July 2, the first in an FDA-approved clinical trial that will eventually see implantation of five patients. The first patient has been identified as a 50-year-old male, but besides providing that identification, the hospital and Abiomed have limited information to details about the operation and issued only meager follow-up reports. They have said only that the patient was progressing rather well considering his poor condition going into the procedure. Beyond supplying these few details, they have maintained a news blackout concerning the patient's identity, despite criticism from some medical ethicists and The New York Times, which challenged the strategy. The hospital and the company have maintained the "quiet period" policy, however, arguing that it is intended solely to protect the patient's family and to allow total focus on the best possible patient outcome.

Meanwhile, in other sectors of the cardiovascular world, Medtronic (Minneapolis, Minnesota), Guidant (Indianapolis, Indiana) and St. Jude (St. Paul, Minnesota) were making their own headlines. On the product front, Medtronic and St. Jude were winners, receiving FDA clearances for new pacemaker devices, while Guidant was turned down for its Contak CD device (see Product Briefs, this issue). Subsequently, Guidant recovered a bit with the announcement of its launch of the Contak CD in Europe and relaunch of its graft system for treating AAA.

About the same time, Guidant won a big legal battle in a patent dispute with St. Jude, which was ordered to pay Guidant $140 million in a patent-infringement case involving implantable cardioverter defibrillators (ICDs) produced by the two companies. A federal court jury found that St. Jude's Contour MD, Profile MD and Photon ICDs infringed on a Guidant patent that expired this past March.

The dispute concerns patents licensed by Guidant in 1994 to Telectronics to settle a lawsuit. St. Jude argued that it got access to those patents when it bought substantially all of Telectronics' heart rhythm management assets in 1996. Guidant said it disagreed and filed suit in November of that year, claiming that St. Jude infringed four ICD patents controlled by Guidant.

Shortly after that decision was announced, an arbitration panel awarded Boston Scientific (Natick, Massachusetts), another key cardiovascular player, $169 million n damages, plus costs and attorneys' fees, in a patent infringement case involving stent-delivery devices produced by Medtronic AVE (Santa Rosa, California), a Medtronic business. The panel ruled that Medtronic AVE infringed Boston Scientific's "Bonzel" patent, and issued a permanent injunction preventing Medtronic AVE from selling the infringed devices, including the S670, S660 and beStent 2 rapid-exchange stent delivery systems and the RIS balloon dilatation catheter.

Medtronic expressed disappointment with the decision, but said that it only covers products generating less than 3% of its worldwide revenues.

Old problem dogs Sulzer's new era

At an extraordinary general shareholders' meeting last month, Sulzer Medica (Winterthur, Switzerland) took the final step to independence from Sulzer AG (also Winterthur), but the new autonomy comes with continuing and nagging problems. "Today is the beginning of a new era for Sulzer Medica," said Dr. Max Link, chairman and interim CEO of the company, which will soon be renamed. Link acknowledged that the "new beginning" was negatively affected by the recall of the firm's Inter-Op hip implant shells in the U.S. and a possible additional problem with tibial baseplates in knee implants produced by the company. He cited the reorganization and new management structure of the firm's orthopedics business and said that nearly 60 scientific investigations into the cause of the implant problems are in process or have been completed, while a consulting firm has initiated quality audits for all of the firm's manufacturing sites.

Sulzer Medica said that the number of patients who had undergone revision surgery of their Inter-Op hip implants totaled some 2,200 and that about 140 patients have had to undergo a revision of their knee implants to rectify tibial baseplate problems. The company said approximately 1,000 lawsuits have been filed in the U.S. involving the recalled Inter-Op shell, 60 of them are seeking certification as class actions. The first hip implant case is scheduled for trial this month. Thus far, two suits have been filed relative to the knee implant problems.

The company continued to say it cannot yet determine the total costs related to the hip and knee implant problems, but it reiterated earlier statements that its insurance coverage probably will not be enough to cover the entire payouts expected.

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