A Medical Device Daily

Dane Technologies (Brooklyn Park, Minnesota) reported acquiring LEVO (Wohlen, Switzerland), a manufacturer and inventor of stand-up wheelchairs for individuals unable to stand on their own. The purchase price of the acquisition was not disclosed.

The merger combines LEVO's standing technologies with Dane's service network, with the companies saying that the benefits for patients include relief from pressure ulcers and improved bladder function, digestion, respiration and circulatory activity. LEVO will operate as a wholly owned Dane subsidiary.

Thomas Raeber, president of LEVO, said, "Dane brings a great service network and reputation for customer service to our partnership."

LEVO's existing U.S. operations will be relocated to Brooklyn Park, from Peachtree City, Georgia.

"LEVO invented the standing wheel chair in 1975. Since that time they have continued to innovate and deliver leading solutions that combine Swiss engineering and precision with great design and reliability," said Dan Johnson, CEO of Dane. "We are proud to be associated with LEVO's tradition of excellence and leadership in technology."

LEVO's products include manual and powered stand-up wheelchairs for adults and children and has introduced the first integrated monitor, which allows the user to measure daily positioning activities.

Dane manufactures power assist solutions used in healthcare, industrial and retail markets.

The Mercanti Group (Minneapolis), an investment banking firm with offices also in Los Angeles and New York, acted as financial advisor to Dane.

Cordis launches Dura Star Rx catheter

Cordis (Miami Lakes, Florida) reported European launch of the Dura Star Rx percutaneous transluminal coronary angioplasty dilatation catheter.

The company said the Dura Star Rx (RX for rapid exchange) catheter facilitates the post-delivery expansion of stents in coronary arteries and is suitable for tackling tortuous anatomy and calcified lesions. It has been designed to provide interventional cardiologists with controlled and even expansion of the balloon to the correct diameter, minimizing the potential for artery damage to the patient.

"The Dura Star Rx performed well under challenging circumstances," said Andreas Baumbach, MD, of Bristol Royal Infirmary (Bristol, UK), who conducted some of the earliest cases with the balloon in Europe. "It is excellent for post-delivery dilatation of stents. It entered and exited the stent easily. It gave controlled and precise expansion to the correct diameter and did not distort at high pressure."

Cordis said the Dura Star Rx catheter is suited for use in both drug-eluting and bare-metal balloon-expandable stents. "Its short and soft tip facilitates crossing stent struts and calcified lesions," the company said. "Designed to reduce the risk of 'kinking' and equipped with a lubricating coating, the Dura Star Rx . . . provides easier delivery to the site of a lesion, especially in challenging cases."

The balloon is available in lengths from 10 mm to 30 mm and diamters from 2.25 mm to 4.0 mm.

Expanded approval for TriActive ProGuard

Kensey Nash (Exton, Pennsylvania) reported receiving expanded European approval for its TriActiv ProGuard blood clot protection device. The company received CE-marking to use its TriActiv ProGuard system in procedures involving the carotid artery.

The system already is approved for saphenous vein graft procedures, in which a patient's blood vessel, usually from the leg, is harvested to bypass a blocked heart artery. The new indication allows use of the system in stenting procedures. The TriActiv ProGuard uses a balloon protection guidewire, a flush catheter and an automated extraction system to prevent stray debris or blood clots from breaking off and causing a stroke. The system can be used in combination with any approved carotid stent, the company said.

For European approval, Kensey Nash used data from a clinical trial showing no major strokes or death in 50 patients where the system was used. The company is enrolling up to 400 patients in a study to support U.S. approval.

CE mark received for Elevess from Anika

Anika Therapeutics (Woburn, Massachusetts) said it received CE-marking for its Elevess product, an injectable soft-tissue filler for facial wrinkles, scar remediation and lip augmentation. Elevess is based on Anika's chemically modified hyaluronic acid (HA) technology and incorporates lidocaine, a local anesthetic.

Charles Sherwood, PhD, president/CEO of Anika, said that Elevess "is designed for longer durability, thanks to its new cross-linking technology and higher concentration of HA."

He said Elevess will be the first HA product containing lidocaine to be commercialized for use in cosmetic dermatology.