A Medical Device Daily

W.L. Gore & Associates (Newark, Delaware), a developer of fluoropolymer-based surgical and medical OEM products, has acquired Tetrad (Englewood, Colorado), a manufacturer of medical ultrasound probes, imaging systems and surgical products for end-users and original equipment manufacturers. Financial terms of the deal were not disclosed.

With the acquisition, Tetrad becomes a wholly owned subsidiary of W.L. Gore.

Gore has developed a number of technologies based on its polymer polytetrafluoroethylene (PTFE), resulting in numerous products for electronic signal transmission, fabric laminates and medical implants, as well as membrane, filtration, sealant, and fiber technologies for diverse industries.

Tetrad, launched in 1985, is a contract-engineering firm specializing in medical ultrasound, and it bills itself as a leading supplier of ultrasound products ranging from standard ultrasound probes and imaging systems to highly specialized surgical and disposable ultrasound probes to major original equipment manufacturers worldwide.

"It's a natural fit," said Russell Shaller, global business leader for Gore's Electronic Products Division, "because Tetrad has already been using Gore Medical Probe Cable Assemblies in its probes. Since Gore is very active in medical imaging products, by combining Tetrad's advanced ultrasound probe technology with the established electrical performance and reliability of Gore cable assemblies, we can better serve our customers in the ultrasound industry and the medical community in general."

Gore reported fiscal year sales of nearly $2 billion.

St. Jude Medical (St. Paul, Minnesota) reported that it has completed the acquisition of the business of Velocimed (Maple Grove, Minnesota), a private company that makes specialty interventional cardiology devices. The transaction was announced on Feb. 15 (Medical Device Daily, Feb. 16, 2005).

St. Jude is paying $74 million in cash for the purchase, with further payments contingent upon future milestones, the earliest of which would be paid in March 2007.

Velocimed's flagship product, under development, is the Premere patent foramen ovale (PFO) closure system.

In conjunction with completion of this transaction, St. Jude said it expects to record a special charge of about $13.8 million in the second quarter related to purchased in-process research and development.

Premere, Velocimed has said, is designed to "redefine" PFO closure. Consisting of two flexible, low-profile, nitinol anchors connected via an adjustable length polyester tether, the system is designed to adapt to the patient's individual anatomy, maximizing closure success while minimizing procedural complications.

The company calls it a first-of-its-kind design intended to enable greater placement control during deployment. The anchors, Velocimed said, "are designed to conform seamlessly to the septal wall to 'hold the door shut,' promoting rapid endothelialization and closure of the PFO."

The system will be available in 15 mm, 20 mm and 25 mm sizes.

The Premere PFO closure system already is approved in Europe. Efforts to initiate a U.S. clinical study of the system under an investigational device exemption (IDE) are currently under way.

PFO is a structural defect of the heart in which a small hole at birth between the right and left atria fails to close in infancy. An estimated 25% of the adult population has a PFO. Though usually considered benign, this condition has been associated with an elevated risk of a stroke. More than 200,000 patients worldwide who survive a stroke each year have a PFO and are potential candidates for PFO therapy.

In other dealmaking: Renal Care Group (Nashville, Tennessee) reported that it has purchased three dialysis programs: HemaCare Dialysis Center (Lansing, Michigan); Mid-Michigan Regional Dialysis Center (East Lansing, Michigan); and Beaverton Dialysis Center (Beaverton, Oregon). The company did not disclose terms of the transactions. Gary Brukardt, president and CEO of Renal Care Group, said, "With a full pipeline of acquisition opportunities, we continue to add to our patient base and affiliate with physician leaders in our key markets.

Michael Hourani, MD, will serve as medical director for the Lansing facility. Lansing Nephrology Group, a division of Mid-Michigan Physicians, will direct the East Lansing facility, and Donald Froom, MD, will serve as medical director for the Beaverton, Oregon, facility.

Renal Care Group is a dialysis services company providing care to more than 30,000 patients at more than 420 outpatient dialysis facilities, in addition to providing acute dialysis services at more than 210 hospitals.