A Medical Device Daily

Medtronic (Minneapolis) reported the European market launch of the Talent Abdominal Stent Graft on the new Xcelerant Hydro Delivery System, which the company cited as featuring a hydrophilic coating designed to aid navigation of the device through “tight and tortuous arteries” by reducing friction with the artery wall.

“The Xcelerant Hydro Delivery System is a significant innovation that will make endovascular repair (EVAR) using the Talent Stent Graft a treatment option for more patients with abdominal aortic aneurysms,” said Dr. Dierk Scheinert, MD, PhD, of Park-Hospital and University of Leipzig–Heartcenter in Germany. He was the leader of the first team worldwide to implant the device using the new delivery system.

“It will simplify the procedure for endovascular interventionalists in treating patients whose iliac arteries are difficult to navigate when they are small and tortuous,” Scheinert said.

The iliac arteries connect the femoral arteries, the entry point for stent grafts, to the aorta, the site of aortic aneurysms. The company said abdominal aortic aneurysms are present in an estimated 1 million people in Europe.

Medtronic said the Xcelerant Hydro Delivery System represents the seventh generation of innovation for the Talent Abdominal Stent Graft, which was introduced in Europe in April 1998. “In bench testing, the Xcelerant Hydro Delivery System was shown to generate a 99% reduction in friction compared to the previous delivery system, which does not have the hydrophilic coating,” the company said.

The Xcelerant Hydro Delivery System features what Medtronic called “a uniquely integrated sheath that contributes to the system’s low-profile characteristics, which are intended to enable excellent tracking and access through small vessels.”

“Katie Szyman, VP and general manager of the Endovascular Innovations business of Medtronic, said the system “represents our latest innovative contribution to this exciting field. Combined with the Talent Stent Graft, Medtronic now offers endovascular physicians in Europe an even stronger option for their EVAR procedures.”

More than 130,000 patients have been treated with Medtronic aortic stent grafts dating to 1995. The company said it offers “the broadest portfolio of endovascular stent grafts in the industry,” including the AneuRx AAAdvantage Abdominal Stent Graft System in the U.S., and the Talent Abdominal, Talent Thoracic and Valiant Thoracic Stent Graft Systems outside the U.S.

Finnish firm introduces herpes test

Mobidiag (Helsinki, Finland) has introduced the Prove-it Herpes test for the identification of herpesviruses. The microarray-based test takes less than three hours to complete and enables simultaneous identification of eight different human herpesviruses.

Herpesviruses cause central nervous system infections, and rapid diagnosis improves likelihood of recovery, Mobidiag said.

The test is initially intended for research purposes, but the company said it expects to receive European approval for use in clinical diagnostics later this year.

“Market potential for the product is enormous,” said CEO Jaakko Pellosniemi. “In Europe alone, over €100 million are spent annually on herpesvirus diagnostics. We believe that Prove-it Herpes will gain a considerable slice of that market.”

He said that what makes Prove-it Herpes unique “is that it combines different technologies and integrates them into a single easy-to-use and capable product.”

In addition to illnesses such as labial herpes, chickenpox and roseola, herpesviruses also can cause serious central nervous system infections such as encephalitis. “Without appropriate treatment, mortality rate from these infections can be as high as 50%,” Mobidiag said.

“We believe that in the future, microarray-based tests will become common in diagnostics due to their simplicity, speed and reliability,” said Pellosniemi. “A clinician can instantly check hundreds of viral and bacterial-based illnesses, offering a huge saving potential for the healthcare industry.”

The Prove-it Herpes test was developed in cooperation with the Hospital Districts of Helsinki and Uusimaa and the University of Helsinki.

KFH Novo device is introduced

Kingfisher Healthcare (Leuven, Belgium) said it has received the CE mark for its KFH Novo medical device for enhancing the healing of chronic wounds.

KFH Novo adds to Kingfisher’s line of non-invasive energy therapies for treating a range of chronic conditions. It uses Kingfisher’s Bio-Electric Stimulation Therapy (BEST) to assist in and improve upon the healing of chronic wounds, including venous leg ulcers, diabetic ulcers and pressure sores.

The company said this form of electrotherapy “enhances the physiological processes of wound-healing at a cellular level, increasing protein synthesis levels, stimulating angiogenesis and fibroblasts, and increasing levels of ATP production to restart and regenerate tissue healing.”

“Treatments for chronic wounds remain a major clinical challenge, as a significant number of patients endure painful, open abrasions for as long as a year,” said Henk Snyman, founder/CEO of Kingfisher Healthcare. “We are [pleased] to offer physicians and patients a safe, non-invasive and cost-effective therapy designed to successfully treat several types of chronic wounds.’

Designed for home use, KFH Novo is portable, convenient and easy to use. Its design elements, including a proprietary touch-screen panel, allows patients to monitor and control their treatments.

Kingfishere said the KFH Novo is expected for sale in the U.S. next year.