A Medical Device Daily

Micrus Endovascular (Sunnyvale, California) said it has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan to market its system for the endovascular treatment of cerebral aneurysms in that country.

The approval includes the MicruSphere, HeliPaq and InterPaq embolic coils.

Micrus said it believes that Japan represents a “significant portion“ of the total Asian market that is estimated to produce about one-third of interventional cerebral vascular disease procedure revenues worldwide.

“Entry into the Japanese coiling market represents a significant revenue opportunity for [us],“ said John Kilcoyne, president and CEO. “We expect to benefit from the continued growth in conversions from the highly invasive craniotomy and clipping procedure, which is currently performed on greater than 75% of aneurysms treated in Japan, to the minimally invasive coiling procedure.“

The company's distribution and service partner in Japan is Goodman Co. Ltd.

“Our growth strategy includes further expansion into the Asian market,“ Kilcoyne said. “We are working with Goodman to obtain approval in Japan for the balance of our product portfolio, including our bioactive Cerecyte products, as well as our UltiPaq coils, catheters and guidewires.“

He added that the company is seeking approval in the first half of this year to enter the Chinese market with a majority of its product line.

Micrus products are used by interventional neuroradiologists and neurosurgeons, primarily to treat cerebral aneurysms responsible for hemorrhagic stroke.

Edwards breaks ground in Shanghai

Edwards Lifesciences (Irvine, California), which focuses on heart valve technologies, reported the groundbreaking for its new heart valve manufacturing facility in Changi North, Singapore. The manufacturing facility, scheduled for completion in October 2007, will be the company's third global manufacturing facility dedicated to producing its Carpentier-Edwards Perimount replacement tissue heart valves.

The company also operates facilities dedicated to heart valve manufacturing at its global headquarters in Irvine and in Horw, Switzerland.

Construction of the 98,000-square-foot facility will begin immediately and is expected to employ up to 500 when operating at full capacity. In the interim, Edwards will continue to operate in a temporary facility in Kaki Bukit, Singapore.

Accuray expands facilities, international offices

To meet demand for its CyberKnife Robotic Radiosurgery System, robotic radiosurgery manufacturer Accuray (Sunnyvale, California) reported the opening of an expanded manufacturing facility in Sunnyvale that doubles Accuray's production capacity and “sized“ to support company growth over the next decade, it said.

Accuray said it also strengthened its international presence by opening expanded regional offices in Paris and Hong Kong to address a surge in sales and installations of the CyberKnife System.

“Accuray's global expansion is further evidence that the CyberKnife System is recognized as an essential tool in the fight against cancer, treating tumors anywhere in the body,“ said Euan Thomson, PhD, president and CEO of Accuray.

The company also opened a new training center in February in Accuray's corporate headquarters, enabling it to provide more clinicians with the information required to make radiosurgery an option for cancer patients.

Kendle to acquire Latin America CRO

Kendle (Cincinnati), a global clinical research organization (CRO), said it has entered into agreements to acquire International Clinical Research (IC-Research), a Latin America CRO, and related companies.

It said the deal, for an undisclosed cash amount, would “further strengthen“ its global clinical development capabilities in the Phase II-IV arena through new operations in Argentina, Brazil, Colombia and Chile. The company said the acquisition would build on existing capabilities in Mexico and Peru.

Kendle's global clinical development business is organized into five regions – North America, Europe, Asia/Pacific, Latin America and Africa.

The company said the deal for IC-Research supports its strategic business expansion in high-growth regions to deliver global clinical trials for its biopharmaceutical customers.

Kendle said it has had an ongoing relationship in recent years on drug-development programs in Latin America.

Candace Kendle, PharmD, chairman and CEO, said the deal would allow her company to be “able to offer our customers the benefit of expanded reach and expertise in Latin America for their global clinical trials.“

She said the acquisition “builds on our thriving operations in the region.“

The transaction is expected to be completed in 2Q06 and is subject to customary closing conditions. It is expected to be modestly accretive to Kendle earnings in 2006.

The acquired operations will operate under the Kendle name and will report to Dennis Hurley, DrSc, vice president, global clinical development-Latin America.

Founded in 2002 by Raul Bozzo, MD, IC-Research has about 25 clinical associates offering extensive CRO and biopharmaceutical industry experience in Phase II-IV clinical development, with significant strengths in cardiovascular, oncology, central nervous system, endocrinology, infectious disease and pain/inflammation.

Upon completion of the acquisition, Bozzo will assume the role of medical director, Latin America and country manager for Argentina and Chile. Mariagabriela Alterio and Alcione Braga will serve as country managers for the new operations in Colombia and Brazil, respectively.

BD Biosciences to distribute Biotrin biomarkers

Biotrin (Dublin, Ireland) has reported entering into an agreement with BD Biosciences , a unit of BD (Franklin Lakes, New Jersey), for the distribution of Biotrin's biomarker line of products for the detection of early organ damage.

BD Biosciences has been named worldwide distributor of the Biotrin biomarkers line to pharmaceutical companies, contract research organizations, universities and research centers.

“This agreement will enable us to capitalize on the growing demand for our expanding biomarker product line and help achieve our goal of making Biotrin biomarkers the No. 1 choice for the detection of early organ damage,“ said Dr. Cormac Kilty, CEO of Biotrin. “With the sales and marketing teams from Biotrin and BD Biosciences working together, we will expand the reach of this product line throughout the world.“

Biotrin identifies and selects biomarkers of interest using its Histomics technology. Those biomarkers provide specific and quantitative information allowing researchers to determine the exact location and amount of damage an organ has undergone and to monitor the progression of damage, either as a result of disease or the administration of toxic compounds.