Ethicon Endo-Surgery snaps up SterilMed

Surgical device maker Ethicon Endo-Surgery will acquire medical device reprocessing firm SterilMed for undisclosed terms under a deal announced Sept. 28. The purchase of privately held SterilMed broadens the Johnson & Johnson subsidiary’s portfolio “and enables expansion in a rapidly growing market segment,” the company said. Headquartered in Maple Grove, Minn., SterilMed’s products and services include medical device reprocessing, equipment repair and pre-owned equipment sales that help health care providers lower their medical device and equipment costs.

Aesculap buys Aragon Surgical

Surgical instrument manufacturer Aesculap gains advanced radio frequency electrosurgical instruments for tissue fusion and cutting through its purchase of Aragon Surgical for undisclosed terms in a deal announced Sept. 26. Privately held Aragon’s Caiman instruments are the only RF devices on the market with an articulating jaw technology, according to Aesculap, which is a division of B. Braun. The purchase complements Aesculap’s existing endoscopic and open surgical instrument offerings, the company said.

Hill-Rom resolves fraud investigation

Hill-Rom will pay $41.8 million to settle federal allegations that it knowingly submitted claims to Medicare for medically unnecessary specialized bed support surfaces, the U.S. Attorney’s Office for the Eastern District of Tennessee announced Sept. 27. Among the Medicare claims targeted were those for patients who had died or were no longer using the equipment, federal investigators said. The settlement, which resolves qui tam whistleblower allegations from current and former Hill-Rom employees, is the largest civil fraud recovery ever in the Eastern District of Tennessee. Hill-Rom denies any wrongdoing in the case.

Boston Scientific settles warranty scheme suit

Boston Scientific will pay the federal government and a whistleblower $9.25 million to resolve Department of Justice allegations that the firm’s Guidant division knowingly failed to grant credits and rebates to hospitals for pacemakers and defibrillators explanted while under a product warranty or other credit program. The company efforts led to inflated costs for replacement pacemakers and defibrillators to federal health care programs, including the Department of Veterans Affairs, the Department of Defense and Medicare, the Justice Department alleged in a Sept. 26 announcement. The settlement resolves a whistleblower suit and investigation in the Middle District of Tennessee.

CMS seeks topics for future NCDs

Medicare agency opens public comment period Sept. 28 on potential topics for future national coverage determinations, three years after drawing up an earlier list of possibilities. (See “ Also see "CMS Floats Topics For Possible National Coverage Determinations" - Medtech Insight, 4 August, 2008. ” – “The Gray Sheet” Aug. 4, 2008.) Since the list was first drawn up, CMS has addressed some of the topics, for example by convening a Medicare Evidence Development and Coverage Advisory Committee meeting on off-label use of bone morphogenetic protein and publishing an NCD on pharmacogenomic testing for Warfarin response. This time around, CMS wants the public to suggest its own list of topics associated with under-use, over-use or minimal benefit within health care settings. Categories for consideration include surgical procedures; diagnostics; imaging; radiology; lab tests; durable medical equipment; treatments for heart, kidney or gastrointestinal disease or cancer; and orthopedic procedures, as well as procedures for the eyes. Comments are due Nov. 27. Once revised, the list will be posted on CMS’ website.

FDA funding child-specific device research

Three University of Michigan projects under the leadership of pediatric surgeon Dr. James Geiger win a two-year, $2.2 million grant from FDA to develop systems or products specific to treating children, the university announced Sept. 23. One team is focused on developing a device to treat short bowel syndrome by lengthening the small intestine without surgery. Another would design and test a smart rapid palatal expander to treat children with cleft palate “using microengineering and lower power circuits that sense and respond to orthopedic forces,” according to the announcement. U. Mich. researchers are also developing non-clotting, biofilm-resistant catheters for newborns. Researchers at the University of Michigan and U. Mich. C.S. Mott Children’s Hospital are conducting the research. The FDA Amendments Act of 2007 includes incentives to encourage industry and researchers to focus on designing devices for children. FDA and industry have collaborated on other pediatric device development projects. (See “ Also see "FDA, Device Firms Take Initiative With New Pediatric Projects" - Medtech Insight, 9 March, 2009. ” – “The Gray Sheet” March 9, 2008.)

Medtronic begins European valve trial

Firm begins European pivotal trial to support a CE mark approval submission for its Engager transcatheter aortic heart valve implant system for patients with severe aortic stenosis. Announced Sept. 27, the 150-patient, 11-site trial will evaluate the transapical valve for patients at high risk for open-heart surgery or who suffer from conditions that make other transcatheter procedures difficult, the company said. The valve is comprised of bovine tissue leaflets and a self-expanding nitinol frame intended to facilitate accurate positioning and stability once implanted. Medtronic gained the technology through its 2009 acquisition of Ventor Technologies. (See “ Also see "Medtronic Catapults Into Transcatheter Valve Market With Billion-Dollar Buys" - Medtech Insight, 2 March, 2009. ” – “The Gray Sheet” March 2, 2009.)

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