A Medical Device Daily

Given Imaging (Yokneam, Israel) said that Japan's Ministry of Health, Labor and Welfare has granted a regulatory approval number for the company's PillCam SB capsule endoscope and that it would begin selling and marketing the device in that country.

"This is a major milestone for our company as it means that we will now be able to sell our flagship PillCam SB in the second-largest healthcare market in the world," said Homi Shamir, president and CEO. "Working closely with our partners, we plan to increase awareness of PillCam SB among Japanese gastroenterologists and build a strong installed base of Given workstations."

He said the company concurrently would work toward obtaining national reimbursement for capsule endoscopy. "We expect this process to take between nine to 12 months," Shamir said.

In 2002, Given Imaging established a Japanese subsidiary with its partners, Suzuken Co., Japan's largest medical device and pharmaceutical distributor, and Marubeni Corp., one of the country's largest trading companies.

Suzuken will serve as the exclusive distributor of PillCam SB in Japan. Given Imaging maintains a 51% controlling interest in the unit, which is responsible for commercializing the PillCam line of products in Japan.

Given Imaging's technology platform is the PillCam Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID software.

The company has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine, which is currently marketed in more than 60 countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile patency capsule to determine the free passage of the PillCam capsule in the gastrointestinal tract.

The PillCam Colon video capsule to visualize the colon has been cleared for marketing in the European Union, and multi-center clinical trials are under way in Europe and the U.S. A capsule to visualize the stomach is also under development.

More than 500,000 patients worldwide have undergone PillCam capsule endoscopy procedures.

Given's headquarters, manufacturing and R&D facilities are in Israel, and it has direct sales and marketing operations in the U.S, Germany and France, and local offices in Japan, Spain and Australia.

Australia okays three Abiomed products

Abiomed (Danvers, Massachusetts) has received regulatory approval in Australia for three of its Impella products. The Australian Register of Therapeutic Goods has approved the sale of the Impella LP 2.5 percutaneous left ventricular assist device, Impella LP 5.0 and Impella LD.

The devices will be distributed in Australia through N. Stenning & Co. Pty. Ltd., Abiomed's distributor for the AB5000 and BVS 5000 Circulatory Support Systems.

According to the National Heart Foundation of Australia, cardiovascular disease is the leading cause of death and disability in Australia, with some 3.7 million Australians affected.

"Abiomed's focus on increasing our global distribution and regulatory approvals provides increased access to potentially lifesaving technologies," said Michael Minogue, predident/CEO and chairman. "We are pleased to work with Australian clinicians and provide our Impella technologies to patients in acute heart failure, to help rest and potentially recover their native hearts."

The Impella 2.5 is a ventricular assist catheter, which is inserted percutaneously in the cath lab via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations.

The Impella 2.5, which provides cardiovascular support for up to five days, is currently available in Europe and is in pilot studies in the U.S under an Investigational Device Exemption (IDE).

The Impella 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down (Impella LP5.0) or surgically (Impella LD). These pumps can achieve flows of up to 5.0 liters per minute, and actively unload the ventricle, reducing myocardial workload and oxygen consumption while increasing cardiac output and coronary and end-organ perfusion.

The Impella 5.0 catheters, which are intended to be used for up to seven days as left ventricular cardiac assist devices, are currently available in Europe under the CE mark and also are in pilot studies in the U.S. under an investigational device exemption.

AION completes spin-out from pSivida

AION Diagnostics (Subaico, Australia) said it has completed its spin-out from parent company pSivida (Perth, Australia). The spin-out was completed in conjunction with AION's corporate advisor, buyout specialist Global Emerging Markets (GEM; New York).

Following the spin-out AION's executive management team retains a 39% shareholding in the company, with GEM a major shareholder at 27% and, following a private placement of new shares, outside investors represent the remaining 34% interest. AION now has 13.14 million shares outstanding.

"This represents an exciting period in the growth of the company," said CEO Dr. Anna Kluczewska. "We look forward to continuing the development of AION's imaging products with European support for global innovation and advancement."

AION Diagnostics is dedicated to the commercialization of medical imaging contrast and molecular imaging agents for early-stage detection of diseases. Founded in 2004, the company has secured strategic alliances with universities, research institutions and industry partners internationally.

Building on a 10-year history of discoveries of porous silicon made by Professor Leigh Canham at the former UK Defence Evaluation Agency (now QinetiQ) and backed by $50 million in cumulative previous investment in the technology, AION has developed mpSi, which has been proven visible across all major imaging modalities.

The company is leveraging the visualization capabilities of the mpSi technology platform with its biodegradable and biocompatible properties to produce imaging product divisions in marking, contrast and molecular imaging agents. One strategic objective is the development of collaborations incorporating the mpSi platform with other materials to create superior versions of existing products.

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