A Medical Device Daily

Kensey Nash (Exton, Pennsylvania) said it has received CE-mark approval for its QuickCat Extraction Catheter.

The QuickCat Catheter is an aspiration system indicated for the removal of blood clots from vessels in the arterial system. The company said the catheter is an easy-to-use, fully disposable system that rapidly removes thrombus from the body.

The device will be sold through Kensey Nash's direct sales force in Germany and through a distribution network for the rest of Europe. It will be launched in the European Union within 30 days.

The catheter received 510(k) clearance in the U.S. in March.

Joseph Kaufmann, president and CEO of Kensey Nash, said, “We are very pleased with the product's market acceptance to date, and as we bring a full line of thrombus extraction products to market, we anticipate that the QuickCat will be an important part of the portfolio for Kensey Nash.”

The catheter is a complementary offering to Kensey Nash's ThromCat Thrombectomy Catheter System, recently cleared in the U.S., for the removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae, and currently under regulatory review in Europe.

The ThromCat System is a more powerful mechanical device with Heliflex technology, designed to remove more organized thrombus. The current market for thrombectomy catheter systems is estimated at about $100 million worldwide.

New plant/lab for Cordis in Ireland

Cordis (Miami Lakes, Florida), a leading maker of drug-eluting stents, plans to build a 180,000-square-foot manufacturing facility, a development laboratory and a finished goods testing center in Cashel, Ireland.

The company said it expects the new facility to be operational during the first half of 2008, producing devices for interventional cardiology markets outside the U.S.

“These new facilities are part of our continuing commitment to innovation and to the physicians who treat patients with coronary artery disease,” said Rick Anderson, company group chairman, Johnson & Johnson (New Brunswick, New Jersey) and worldwide franchise chairman for the Cordis unit. “They are designed to support demand for the current Cypher family of drug-eluting stents, including the Cypher and Cypher Select Plus sirolimus-eluting coronary stents.”

Anderson said the new plant also will support “innovative next-generation interventional and drug/device combination products.”

The facility will employ more than 400 in manufacturing, with about 60 additional positions at the finished goods testing center and at the development laboratory.

Cordis reports that the Cypher drug-eluting stent (DES) has been used to treat more than 2 million patients with coronary artery disease and is available in more than 80 countries.

The second-generation Cypher Select stent was launched in Europe, Asia Pacific, Latin America and Canada in 2003. And the Cypher Select Plus, which Cordis said is the first third-generation DES device, received the CE mark last month and will be available outside the U.S. beginning late in 3Q06.

Czura acquires Chiltern

Czura Thornton (London) said it has acquired Chiltern International (Slough, UK), which it termed “one of the world's leading independent clinical contract research organizations,” for an undisclosed sum.

Czura Thornton, a private investment group led by Antony Czura and Nick Thornton, has acquired more than 90% of Chiltern, with the remainder expected to be acquired over the next few weeks.

Established in the UK in 1982, Chiltern has experience in running national and international Phase I-Phase IV clinical trials across a broad range of therapeutic categories. The company has offices throughout the U.S. and Europe and in India, with headquarters in Slough, UK, and Carlsbad, California.

Chiltern provides a wide range of services to the medical device, pharmaceutical and biotechnology industries, along with clinical contract personnel services to pharmaceutical and biotechnology clients.

Simon Garnham, co-founder of Chiltern, has stepped down as CEO of the company. Thornton, who becomes executive vice chairman, also will act as CEO until a new CEO is selected. Roland Boyd has been appointed CFO.

“We have long admired Chiltern's reputation in the industry for providing a comprehensive range of high-quality products and excellent customer service,” said Thornton. “We look forward to bringing the investment and resources needed for the next phase of the company's growth as a global, full-service clinical CRO.”

Czura Thornton's acquisition of Chiltern is made as general partner for the Galaxy Limited Partnership. Czura Thornton's other investments include medical diagnostic laboratories and commercial search directories and services.

Nasdaq Global Select listing for Qiagen

Qiagen (Venlo, the Netherlands) reported that it has been included in the new Nasdaq Global Select Market, which the company said is reported to have the highest initial listing standards of any exchange in the world based on financial and liquidity requirements.

Prior to the change, which occurred early this month, Qiagen's shares had been listed on the Nasdaq National Market. Its shares continue to be traded under the ticker QGEN.

Qiagen, a global provider of pre-analytical sample preparation products enabling genetic and protein analysis, also is listed on the Prime Segment of the Frankfurt Stock Exchange.

MDD's web site looking to net complete calendar listings

Among the variety of features on Medical Device Daily's web site – www.medicaldevicedaily.com – is a calendar listing of upcoming medical device and med-tech conferences, as well as drug conferences and health management events having some relationship to the med-tech industry and healthcare technology development.

We are committed to making this calendar as comprehensive as possible for our readers – in as far in advance as possible – but need your help to do so, considering the number of these conferences that take place each year.

If you are attending, or know of, a conference appropriate for this listing but not yet posted on the link, please contact MDD Karen Young with information concerning the conference, the sponsoring group and dates/times.

Contact her by e-mail at karen.young@thomson.com, or by phone at 404-262-5423.