A Medical Device Daily

Two California-based medical device firms have reported decidedly different outcomes of their bids to have products approved in two Asian countries.

Staar Surgical (Monrovia, California), a manufacturer and marketer of minimally invasive ophthalmic products, said it has received approval from the Korean Food and Drug Administration (KFDA) to market the Staar Visian Toric lens (TICL) in South Korea.

The company said the TICL lens is the first of its kind to receive KFDA approval. Used as part of a customized refractive procedure, the Staar product is a refractive lens that provides treatment for the most prevalent sight deficiencies – nearsightedness and astigmatism. It corrects these vision deficiencies without the removal or destruction of corneal tissue.

David Bailey, president and CEO of Staar Surgical, said the approval “gives Korean ophthalmic surgeons and patients access to a customized refractive procedure which yields excellent outcomes.” He said the TICL product “will allow us to serve a broader population and further build our presence in our second-largest market for the myopic ICL.

Bailey said the South Korean market features “higher levels of myopia and astigmatism,” adding that the approval “will deliver a meaningful increase to our overall refractive business.”

Staar’s ICL has received CE marking, is approved for sale in about 40 countries and has been implanted in more than 40,000 eyes worldwide. It is currently under review by the FDA.

Doing less well on the Asian approval front is Endologix (Irvine, California), which reported that an Expert Panel for the Pharmaceutical and Medical Devices Agency of the Japanese Ministry of Health, Labor and Welfare (MHLW) has declined approval of the company’s PowerWeb endoluminal stent graft (ELG) due to the original Japanese clinical trial design and execution.

The company said the decision was “not the result of clinical issues with the Endologix PowerWeb device or patient outcomes from the Japanese clinical trial.”

It said the Expert Panel has requested that Endologix submit its Powerlink System for approval using its existing U.S. clinical trial data. The review will then be based on the Powerlink data, with the PowerWeb clinical trial data being used to fulfill the requirement for a Japanese clinical trial.

The Powerlink System and the PowerWeb System, which was a predecessor to the Powerlink, are endoluminal stent graft (ELG) and catheter-based treatments for abdominal aortic aneurysms (AAA). Endologix completed the first AAA clinical trial in Japan, including the required six-month patient follow up. Six centers used the PowerWeb System for elective endovascular aneurysm repair in 79 patients.

Paul McCormick, Endologix president and CEO, said, “While we are disappointed with this decision, which delays our entry into the Japanese market, we are grateful that the Expert Panel will allow a submission for the Powerlink System supported by our outstanding U.S. trial data, and their allowance to use the PowerWeb clinical data as a supplement in the submission.”

McCormick noted that the Powerlink System is the ELG system the company currently markets in the U.S. and Europe, “and we believe that in the long run, manufacturing of a single ELG platform will be beneficial in our worldwide marketing plan.” The system was approved for U.S. sale last fall (Medical Device Daily, Nov. 2, 2004).

He said Endologix already is in the process of preparing for the Powerlink submission for approval in Japan, including translating the U.S. pre-market approval application and clinical data into Japanese. “Although we are unable to project the timeline for . . . approval, we believe that Endologix may still be the first or among the first to introduce an ELG device for abdominal aortic aneurysms (AAA) in the Japanese market.”

McCormick added that his company does not believe that the delay in getting product approval in Japan will have “a material financial impact on us over the next few years.”

Schein adds Aussie, New Zealand firms

Henry Schein (Melville, New York) has acquired Halas Dental Ltd. and Shalfoon Bros. Ltd., providers of dental merchandise and equipment in Australia and New Zealand, respectively. Henry Schein purchased the businesses from Australian Pharmaceutical Industries Ltd.

Transaction terms were not reported.

Halas Dental and Shalfoon are expected to contribute combined revenues of approximately A$80 million in the first 12 months of operations after the acquisition. Henry Schein said it expects the acquisition to be “slightly accretive” in 2005, with a greater contribution to earnings in 2006 and beyond.

The acquisition adds more than 50 sales representatives to Henry Schein’s existing Australian and New Zealand sales force, numbering about 60.

Stanley Bergman, chairman and CEO of Henry Schein, said Halas and Shalfoon “have enjoyed a long and successful heritage in Australia and New Zealand, respectively, resulting in a strong brand identity, numerous product exclusives and an excellent customer base. With this acquisition and [our] existing Australian and New Zealand operations, we are firmly positioned as a leading dental distributor in these two countries.”

Andrew Hoggard, Halas general manager, and Gail Stewart, Shalfoon Brothers general manager, have joined the Henry Schein organization. Gordon Anderson, general manager for Henry Schein’s current Australian/New Zealand operations, will oversee the Halas and Shalfoon businesses as well.