A Medical Device Daily
AGA Medical (Plymouth, Minnesota) said it has received approval from the Japanese Ministry of Health, Labor and Welfare for its Amplatzer Duct Occluder (ADO). The ADO is a percutaneous, transcatheter occlusion device used for the non-surgical closure of patent ductus arteriosus (PDA), a common type of congenital heart defect that occurs when a blood vessel known as the ductus arteriosus fails to close after birth, as it normally should.
President/CEO John Barr said, "Our exclusive distribution partner, Japan Lifeline Co., will immediately apply for reimbursement and intends to launch the product to the market in the first half of 2009 following receipt of reimbursement." All medical devices in Japan must receive reimbursement approval prior to marketing of the product.
The ADO is AGA Medical's second device to receive approval in Japan. The company's Amplatzer Septal Occluder was approved in 2005 and launched in May 2006.
The ADO is intended for the closure of PDAs larger than 4 mm, which represent roughly 30% of total PDA defects. Shaped to achieve consistent, effective closure, the device is made of self-expanding nitinol mesh and is designed to be introduced in a minimally invasive fashion through a catheter.
The ADO features a retention "skirt," which allows the device to be positioned properly and remain in place at the entrance to the duct.
The Amplatzer Duct Occluder was granted the CE mark in Europe in February 1998 and FDA approval in May 2003.
A second-generation model – ADO II – has been granted CE-mark approval in Europe and can be delivered through even smaller catheters and is appropriate for both smaller ducts and ducts with different geometries. AGA has a clinical trial under way to support approval for the ADO II in the U.S.
Merge retains China operations
Merge Healthcare (Milwaukee), a medical imaging solutions provider, reported that it has reacquired its operations in China. Earlier in 2008, Merge pursued the divestment of all of its international operations, including China.
The sale of Cedara Software Shanghai Co. Ltd. (ShanghaiCo) to Inqgen Technology Ltd., initiated by former Merge executives in March 2008 but not finalized, has been terminated by mutual agreement of the parties. "As we have discussed on our two prior earnings calls, we believe in the growth of our core business on an international scale and therefore terminated the planned divesture of our European operations in June," said CEO Justin Dearborn. "Now with the reacquisition of our China operations, we feel that we are well positioned to execute on our global strategy."
He added, "If it is not today, China will soon be the largest market in the world for our products. We feel it is critical to have sales, marketing, customer support and an engineering presence in China to be successful."
Inqgen has participated fully in the transfer to date, working with employees of ShanghaiCo on the communication of transition plans.
Zhong Wang, director of Asia business operations for Merge OEM, will immediately assume management of the Shanghai operations.
"Merge has had success in the recent past in bringing the Cedara toolkits and technologies to the Chinese medical imaging market," said Wang. "I look forward to renewing and expanding these efforts for increased growth and providing a local presence once again."
Merge Healthcare's solutions serve radiology practices, outpatient imaging centers, hospitals, pharmaceutical companies and device manufacturers worldwide.
China okays Restylane
Q-Med (Uppsala, Sweden) has obtained registration approval for Restylane in China. An application for sales approval will be submitted shortly and it is estimated that sales of the product will begin at the end of 2Q09.
"There is a large appetite for new things in China and great respect for products from the West. We are therefore very pleased about this registration approval, which means that Restylane will be the first hyaluronic acid product intended for the cosmetic market in China," said Q-Med President/CEO Bengt Ágerup.
Q-Med manufactures primarily medical implants. The majority of the products are based on the company's NASHA technology for the production of stabilized non-animal hyaluronic acid.
The product portfolio today includes Restylane for filling lines and folds, contouring and creating volume in the face; Macrolane for body contouring; Durolane for the treatment of osteoarthritis of the hip and knee joints; Deflux for the treatment of vesicoureteral reflux in children; and Solesta for the treatment of fecal incontinence
Sales are made through the company's own subsidiaries or distributors in more than 70 countries.
Asia MEDTECH to be rescheduled
Asia MEDTECH 2009, which had been scheduled to be held from March 25-28 in Singapore, along with Global-Asia Trade Exchange Medical Technology 2009, scheduled to take place on March 26-27, will be postponed to a later date, organizers said.
The events, organized by the Singapore Precision Engineering & Tooling Association, sought to promote engineering suppliers to the medical equipment and device manufacturing sectors in Singapore and Asia.