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HEADNOTE

Edwards Sells German Unit in Perfusion Divestiture

FDA Panel Studies Micro Therapeutics' Onyx; OC Hospitals Part of Coronary Network

Edwards Lifesciences Corp., the Irvine-based heart device maker,

plans to sell its German perfusion services unit to WKK GmbH of Mainz, Germany. Terms of the deal weren't disclosed.

The Edwards unit employs about 20 people, primarily clinical perfusionists and technicians who operate breathing and blood flow devices during heart surgery.

The operation generated some $3.5 million in revenue during the first half of this year. Edwards said it plans to take a $3.3 million pretax loss from the sales as part of its second-quarter results.

"It wasn't a core business," Edwards spokesman Barry Liden said. "This was an extension of our divestiture in 2001."

Back then, Edwards sold Edwards Lifesciences Cardiovascular Resources Inc., its San Diego-based domestic perfusion services subsidiary to Fresenius Medical Care AG, another German company, for about $45 million in cash.

Perfusion uses artificial blood pumps to propel blood through the body of surgery patients, replacing the function of the heart as the cardiac surgeon operates.

Open-heart surgeries are predicted to decline because of the advent of devices such as stents-tiny, stainless steel mesh tubes used to keep clogged arteries open.

"Most people say that cardiac surgeries are going to decrease 25% the first 12 months after the onset of drug-eluting stents," said Ryan Rauch, then with Adams, Harkness & Hill in San Francisco, earlier this year.

In particular, the cardiac sector is seeing a buzz with the development of drug-eluting stents.

Drug-eluting stents are coated with medications that travel from the stent into the blood vessel's wall, preventing scar tissue from forming and thus preventing arteries from clogging up again.

Edwards has been working to shed slow-growth businesses ever since its 2000 spin-off from Baxter International Inc. of suburban Chicago.

Edwards sold Novacor, maker of a heart assistant system, to World Health Corp. of Ottawa, in 2000.

In 2001, the company sold Bentley Laboratories, a maker of disposable oxygenators, blood reservoirs and filters used during heart surgery, to Germany's Jostra AG.

Edwards has "spent much of its life as an independent company divesting the parts of the business that it did not like," said Dr. Alexander Arrow, a medical device analyst with Lazard Freres & Co. in New York.

Meanwhile, Edwards, under the direction of Stuart Foster, corporate vice president of technology and discovery, has been on a shopping spree to pick up a number of smaller products as part of its larger bid to expand beyond its core heart valve franchise.

Edwards is Orange County's largest medical device maker, with 2002 sales of $704 million and a market value of $1.9 billion at recent check.

FDA Taking Closer Look

Micro Therapeutics Inc., an Irvine-based medical device maker, is on its way for a date with the Food and Drug Administration.

Micro Therapeutics makes minimally invasive medical devices for diagnosing and treating vascular disease.

Micro Therapeutics' liquid embolie product, Onyx, is set to be presented and discussed at an Aug. 5 meeting of the PDA's Neurological Devices Panel, a public advisory committee.

The group is set to look at Micro Therapeutics' clinical data regarding Onyx for the treatment of arteriovenous malformations.

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Micro Therapeutics collected the clinical data under an PDA-approved clinical trial and submitted an application for approval to sell Onyx in the U.S. for arteriovenous malformations in March.

The panel's clinical data review is part of the regulators' evaluation process.

In other Micro Therapeutics news, US Bancorp Piper Jaffray device analyst Thom Gunderson upgraded the company's stock to "outperform" from "market performer."

Bits and Pieces:

Seven Orange County hospitals are part of a newly established "centers of expertise" coronary artery bypass graft network by Blue Cross of California: Anaheim Memorial Medical Center; Hoag Memorial Hospital Presbyterian, Newport Beach; Mission Hospital Regional Medical Center; Saddleback Memorial Medical Center, Laguna Hills; St. Joseph Hospital, Orange; St. Jude Medical Center, Fullerton and Western Medical Center-Anaheim. The network is based on statistical reports examining volumes and quality of outcomes of such procedures ... Sun Healthcare Group Inc., Irvine, said Omnicare Inc. of Covington, Ky., completed its buy of the SunScript pharmacy services business. Omnicare agreed to buy SunScript for up to $90 million in cash ... St. Joseph Hospital in Orange introduced the da Vinci robotic surgical system late last month. The da Vinci system, which is used in procedures such as cardiology and obstetrics, also can be found at UCI Medical Center in Orange ... Children and Families Commission of Orange County, Irvine, allocated $750,000 among seven organizations for developing injury prevention programs for young children. Kimberly Chavalas Cripe, chief executive of Children's Hospital of Orange County, Orange, is the commission's newly elected chairperson.

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