A Medical Device Daily

Misonix (Farmingdale, New York), a developer of ultrasonic device technology for the treatment of cancer and other chronic health conditions, reported its plans to bring the Sonatherm 600, used for high-intensity focused ultrasound (HIFU) treatment of soft tissue, including cancerous tissue in the kidney, into China.

The Sonatherm has been developed by Misonix in connection with the worldwide rights that it acquired from Focus Surgery (Indianapolis), a HIFU developer.

As part of the company’s strategy to enter into China, a distribution agreement was formed with Acton Medical Device (Guangzhou, China), which has a sales team of 156 covering more than 20 provinces.

Acton will be responsible for conducting clinical studies and acquiring all necessary government approvals for the sale of the Sonatherm in China. Misonix will manufacture the device at its facilities in Farmingdale and will ship the product to Acton for use by its partners in the Chinese medical community for satisfying regulatory requirements as well as establishing regional branding, the company said.

Based on clinical studies conducted for Misonix in other parts of the world, the Sonatherm has been demonstrated as an advanced product for minimally invasive procedures that ablate cancerous tissue without the need to puncture the kidney organ.

Michael McManus Jr., president/CEO of Misonix, said, “We are excited about this new relationship with Acton and about the introduction of our medical device as the first minimally invasive HIFU treatment of kidney cancer in China. Misonix is clearly strengthening its position as global leader in the development of ultrasonic medical devices. We have now received the first clearance [for the Sonatherm] under 510(k) from the FDA in the U.S., completed the very first procedures in Europe for the treatment of cancer in the human kidney, and, now, achieved a milestone as the first to enter China with such a medical device.”

Sherry Gong of Acton said, “There is a great need for these products in China and we look forward to leveraging our growth in this very large market with products that only Misonix has developed.”

Enrollment completed in LeMaitre trial

In other device news from China,LeMaitre Vascular (Burlington, Massachusetts) reported the enrollment of the 30th and final patient in the EndoFit Thoracic Stent Graft Clinical Study in that country.

The company said the objective of the study is to obtain data in support of approval of the EndoFit Thoracic Stent Graft from the Chinese State FDA (SFDA). Completion of patient enrollment marks the start of a six-month follow-up and observation period.

George LeMaitre, president/CEO and chairman, called the enrollment figure “a key regulatory milestone in this rapidly emerging endovascular device market.”

The EndoFit Thoracic Stent Graft is used to treat aortic aneurysms. The device’s encapsulated design prevents its stents from contacting the bloodstream or the vessel wall, thus allowing a wider range of stent graft sizes, including tapered and custom grafts, to fit a wider range of patient anatomies than many competing products.

Dr. Weiguo Fu, director of the endovascular department at China Fudan University Zhongshan Hospital , said, “The radial force of the proximal end of the EndoFit Thoracic Stent Graft seems superior, as we have not seen any migration post-implantation. Also, the flexibility of the delivery sheath allows for a controllable delivery around the aortic arch.” Fu is participating is the study along with Dr. Wei Guo of Beijing 301 Hospital and Dr. Shangdong Xu of Beijing Anzhen Hospital .

The EndoFit Thoracic Stent Graft is currently sold in the European Union and a small number of other foreign jurisdictions. It is not yet cleared for sale in the U.S.