A Medical Device Daily

Staar Surgical (Monrovia, California) reported receipt of CE-mark approval for its KS-X Preloaded Hydrophobic Acrylic Injector for use in minimally invasive cataract surgical procedures.

Staar has been offering the KS-X system, which mates a preloaded delivery system manufactured by Staar Japan with an independently sourced acrylic lens, in the Japanese market for two years. The Staar system enables lens delivery into the eye through a 2.8 mm incision and is compatible with the most commonly used small-incision cataract extraction procedures.

The company said it is the only preloaded lens delivery system in the world that provides single or bi-manual injection options in a single design, "allowing for the smoothest IOL injection methods compared with traditional delivery systems."

David Bailey, president of international operations for Staar, said, "Receipt of the CE mark is an important accomplishment and a validation of Staar Japan's expertise in the development of preloaded delivery systems for foldable IOLs that enable precise delivery of the lens during cataract surgeries."

He added, "Staar Japan's expertise in delivery systems for intraocular lenses, including their use with advanced material lenses, was one of the major factors behind our recent creation of operational Centers of Excellence throughout our global operations, which is expected to drive continued product enhancements as we move forward."

A foldable IOL is a prosthetic lens used to replace a cataract patient's natural lens after it has been extracted in minimally invasive, small-incision cataract surgery.

Staar manufactures IOLs out of silicone and Collamer, the company's proprietary biocompatible collagen copolymer lens material. Staar Japan introduced the first preloaded IOL lens injector system to the international markets in 2003.

The company introduced its Centers of Excellence project in 4Q08. It is designed to enhance Staar's ability to deliver innovative surgical products to customers by focusing the Japanese operations on developing and manufacturing innovative lens delivery systems and the U.S. operations on optics design and manufacturing. The expected result is cost savings and more rapid introduction of new technologies.

First shipments of the product in key European and Australian markets are expected to begin late this month. The acrylic lens-based preloaded injector is not approved for sale in the U.S.

Cystic fibrosis tests launched

Luminex (Austin, Texas) reported launching two new cystic fibrosis (CF) tests in Europe, the xTAG Cystic Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2, as CE-marked IVD products under the European Directive on In Vitro Diagnostic Medical Devices.

The new xTAG tests will be used to provide assistance in CF screening for newborns and confirmatory diagnostic testing in newborns and children. The tests also can be used for carrier testing in adults of reproductive age.

Cystic fibrosis can only be inherited when both of a child's parents carry a CFTR gene mutation that causes the disease. About 36,000 Europeans have cystic fibrosis. Each year 2,500 children with the disease are born. According to the European Cystic Fibrosis Society, as many as one in 30 Europeans are carriers of a CF-causing gene mutation.

"The geographic distribution of CFTR gene mutations differs significantly among the European populations," said Milan Macek, professor of medical and molecular genetics in the Division of Clinical Molecular Genetics and the National Cystic Fibrosis Center at University Hospital Motol and 2nd School of Medicine Charles University (Prague, Czech Rebublic). "The possibility of having a test that can cover a wide range of mutations found in different ethnic groups is very important and will allow doctors to have better confidence around CF diagnosis, especially when we have cases where the ethnicity of the patient is difficult to assess."

Lumenix said the xTAG Cystic Fibrosis 39 Kit v2 "can quickly and accurately detect up to 39 of the most common CFTR gene mutations from a child or parent's blood sample or bloodspot in a matter of hours. The xTAG Cystic Fibrosis 71 Kit v2 can screen for all of the genetic mutations in the xTAG Cystic Fibrosis 39 Kit v2 plus an additional 32 mutations including those that are typically found in specific ethnic populations."

The xTAG tests also are designed to be fast and easy for use, requiring only about one hour of hands-on time to process 48 purified samples. They offer physicians the ability to select the CFTR gene mutations for which they want to test.

LinkMed share issue oversubscribed

A new share issue implemented by LinkMed (Stockholm, Sweden) was oversubscribed by 41%. LinkMed will receive about SEK 91.3 million ($11.82 million), before issue expenses.

Of the new share issue, 98.5%, corresponding to 7,192,444 shares, were subscribed for on the basis of subscription rights. Applications to subscribe for shares without the support of subscription rights were made for about 42.7% of the issue, equivalent to 3,118,527 shares.

"Naturally, we are very pleased that such great interest was shown in LinkMed, said CEO Ingemar Lagerlöf. "The new share issue will give us the opportunity to create a well-positioned and profitable transplantation sector company by combining AbSorber and Olerup, in which the first steps may be a joint sales organization and the coordination of the resources of the two companies."

He added, "We also now have the opportunity to continue to support the development of BioResonator, Biovator, Likvor and Ortoviva, all of which are at very interesting stages, with products close to market launch."

As a result of the new issue, the number of LinkMed shares will increase by 7,300,873 to 16,061,921 shares.

LinkMed develops life science companies in collaboration with innovators and other financiers. It has created a portfolio of 12 companies, four in drug development and biotechnology and eight in diagnostics and medical technology.

The company's principal shareholders include, among others, FastPartner, Koncentra Holding and the founder, Lagerlöf.