A Medical Device Daily

Abiomed (Danvers, Massachusetts) reported receiving the CE mark for its intra-aortic balloon (IAB) and iPulse console platform. That approval allows the new combination console and disposable balloon to be sold in all European Union countries, as well as many other countries worldwide that accept the CE markl for registration.

The company describes the IAB as “an easy-to-insert, minimally invasive technology designed to enhance blood flow to the heart and other organs for patients with diminished heart function.”

The iPulse combination console platform drives Abiomed’s IAB, BVS 5000 and AB5000 circulatory support systems, as well as new product introductions planned by Abiomed in the future. It also is designed to be compatible with other original equipment manufacturers’ balloons.

The technology is intended to provide circulatory support for patients suffering from acute or sudden cardiovascular failure. In many countries outside the U.S., the iPulse platform will provide short-term and longer-term support, including bridge to transplant.

Abiomed’s IAB was recently cleared by the FDA and culminates more than two years of internal research and development. The 8 Fr device is inserted percutaneously into a patient’s descending aorta and inflates and deflates in counterpulsation to a patient’s heart rhythm.

The company said the IAB was subject to “extensive reliability testing,” and successfully demonstrated a life of more than 8 million cycles, which equates to more than 90 days of continuous operation.

“Receiving CE-mark approval for our intra-aortic balloon pump system is a significant milestone for Abiomed,” said Michael Minogue, chairman, CEO and president. “With this approval, we expand our presence in Europe and we will provide patients and physicians with greater access to our extensive portfolio of circulatory support technologies including Impella and the AB5000.”

Abiomed said it expects to begin shipping its integrated iPulse console outside the U.S. during the company’s fiscal fourth quarter ending March 31.

It has submitted a premarket approval (PMA) application supplement for the iPulse to the FDA. Pending regulatory approval in the U.S., Abiomed’s initial introduction of the new iPulse to U.S. heart hospitals is expected this summer.

2.45M shares sold by Amphion

Amphion Innovations (London), a developer of life science and medical technology businesses, reported closing a fundraising of 612,500 (before expenses) on Dec. 29, with the shares being allotted and issued on Jan. 3.

In the placement, the company issued 2.45 million new ordinary shares at 25 pence a share.

The company said the net proceeds from the placement will be used to invest in “new and identified” opportunities.

Amphion said application will be made for the new shares to be admitted to trading on the Alternative Investment Market (AIM), with admission expected to occur on Friday. The shares will rank pari passu in all respects with the existing ordinary shares of the company that are currently traded on AIM. Following admission, the total number of shares in issue will be somewhat more than 100.1 million.

As part of the placement, Richard Morgan, a director of Amphion, acquired 300,000 ordinary shares at 25 pence a share. Morgan now has 16,289,703 ordinary shares, representing just under 16.3%.of the total number of ordinary shares in issue following the placement.

Also, Amphion Capital Partners, a related entity and existing shareholder, acquired 1,025,000 ordinary shares, bringing its holdings to 8,025,000 shares, about 8.017% of the total number of ordinary shares in issue.

The shares are registered in the name of Amphion Capital Partners, whose partners include Morgan, Robert Bertoldi, Richard Mansell-Jones, Anthony Henfrey and Jim Macaleer, all of whom are directors of Amphion Innovations.

Amphion forms, finances, manages and develops life science and technology companies, primarily in the U.S. and UK, in partnership with corporations, governments, universities and entrepreneurs seeking to commercialize their intellectual property.

Symmetry buys aerospace product maker

Symmetry Medical (Warsaw, Indiana), a provider of products to the global orthopedic device industry, has acquired Whedon, the holding company of Clamonta (Warwickshire, UK), in a deal valued at $10 million in cash.

Clamonta, which has a 50-year history of supplying precision products to the global aerospace industry, is expected to report 2006 revenues of about $10 million. Its products will help bridge Symmetry’s Total Solutions business model into the aerospace industry.

Brian Moore, president/CEO of Symetry, said, “This is a focused acquisition to expand our added-value operations within our existing product expertise and supports a major customer by providing a more complete Total Solution.”

The company said it expects the acquisition to be “slightly accretive” in 2007.

Symmetry is a provider of implants and related instruments and cases to orthopedics, and it designs and produces products for companies in other segments of the medical device market, including dental, osteobiologic and endoscopy sectors; and it provides specialized products and services to non- healthcare markets, such as aerospace.

Gebauer Medizintechnik forms U.S. unit

Gebauer Medizintechnik (Neuhausen, Germany) has launched a new U.S. business, Gebauer Ophthalmic Instruments in North Palm Beach, Florida to manage U.S. sales and marketing for all of Gebauer’s surgical equipment, including its EpiVision line used in minimally invasive Epi-LASIK surgery.

Steffen Gebauer, company CEO, called formation of the new unit “an important step in pursuing our corporate strategy to come closer to our customers worldwide . . . . It will also enable us to further build our business and to participate in the growing U.S. market for surface ablations with our EpiVision Epikeratome.”

He added: “Gebauer is also there for the doctors wanting to advance their practices by introducing the best technology to their patients. Epi-LASIK is arguably superior to LASIK for a patient’s long term vision care, and more comfortable, as well as faster than PRK.”

Gebauer Medizintechnik is a provider of precision engineering design, component integration, electronics development and software creation for medical device manufacturing.