A Medical Device Daily
NovoStent (Mountain View, California) reported that physicians in Germany have implanted 250 mm stents as part of the European clinical trial evaluating the use of the company's peripheral stent in the treatment of superficial femoral and popliteal artery disease.
The first case with the 250 mm stent was performed by Sven Braunlich, MD, and Dierk Scheinert, MD, in Leipzig, Germany. Scheinert, head of the department of angiology at the University of Leipzig Heart Center and Park Hospital, is the principal investigator in NovoStent's multi-center European study.
He said, "The stent is more flexible than any other that I have used, which is critical since stents used to treat real-world, long peripheral lesions have been shown to be more prone to fracture and restenosis."
Thomas Zeller, MD, director of the department of vascular medicine at the Heart Center (Bad Krozingen, Germany), also implanted the device and said, "I was impressed with the exact placement of such a long stent and the optimal clinical outcome for my patient."
NovoStent's self-expanding stent technology provides a wide range of vascular and non-vascular therapies, with the treatment of femoropopliteal disease being the first vascular application of the technology.
"The ability to deliver an extremely long stent is just one of the unique aspects of our technology platform and will help facilitate the evolution of patient care relative to the treatment of longer lesions," said G. Ray Martin, PhD, president/CEO of NovoStent. He added, "The 250 mm device is a natural extension of our clinical offering that has been used to treat more than 60 patients."
Hugo Londero, MD, chief of hemodynamics and transcatheter interventional services at Sanatorio Allende (Cordoba, Argentina), was the first physician to implant NovoStent devices in the SFA as well as the popliteal artery. Physicians have previously avoided placing stents in the popliteal artery for fear of stent fractures.
The company's stents feature a helical macrostructure, which NovoStent said maximizes flexibility, durability and radial strength, in addition to a micro-cell structure that can be customized for different vascular and non-vascular anatomies to achieve "optimal lumen coverage and prolapse control."
NovoStent's integrated delivery system is designed to provide easy deployment and accurate delivery.
CE mark for NeoVista's wet AMD device
NeoVista (Fremont, California) said that it has received CE mark approval for its focal epiretinal brachytherapy device, used in a new treatment for wet age-related macular degeneration (AMD).
That approval allows NeoVista to distribute and sell its product throughout all European Union countries, offering a new treatment option for 2 million Europeans who are afflicted with wet AMD.
President/CEO John Hendrick said, "We hope to bring our treatment to millions of European patients with wet AMD who are seeking a more cost-efficient treatment option that will be potentially as effective as or better than the current standard of care."
The NeoVista technology delivers beta radiation (using strontium 90) for treatment of wet AMD. Similar in size and appearance to a fountain pen, the surgical device delivers focused beta radiation to leaking blood vessels that affect central vision, without causing damage to the surrounding tissues.
To market the therapy in the U.S., NeoVista is currently in the midst of conducting its final Phase III clinical trial, the CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) multi-center study that is enrolling 450 patients at clinical centers worldwide.
Distribution accord for InnerCool
Cardium Therapeutics (San Diego) and its operating unit, InnerCool Therapies, said InnerCool has entered into a European commercialization agreement with Euromed Medizinisch, a distributor of cardiology products.
Under the terms of the agreement, Euromed will have exclusive marketing, sales and distribution rights in Austria, Germany and Switzerland for InnerCool's line of temperature modulation systems.
The agreement covers CoolBlue, a surface-cooling temperature modulation system, which was launched in the U.S. market during 4Q07, as well as InnerCool's premium-priced RapidBlue endovascular cooling system, which is expected to be launched in the U.S. in 2Q08.
Euromed's marketing and sales force, is expected to begin sales of CoolBlue consoles and disposables in Europe this quarter, with sales of RapidBlue consoles and disposables expected to begin next quarter.
Reinhold Eder, CEO of Euromed, said, "We believe InnerCool is the only company positioned to offer a comprehensive portfolio of best-in-class temperature modulation solutions for physicians and healthcare providers in this rapidly expanding therapeutic area."
Patient temperature modulation is a rapidly-advancing field focused on preserving ischemic tissue and improving patient outcomes following major medical events such as stroke, cardiac arrest and heart attack, as well as in the management of patients experiencing trauma or fever. Such an approach is intended to cool patients in order to reduce cell death and damage caused by ischemic events in which blood flow to critical organs such as the heart or brain is restricted, and to prevent or reduce associated injuries such as adverse neurologic outcomes.
EQ2 signs UK distributor
Information systems software company EQ2 (Burlington, Vermont) reported signing an exclusive distribution agreement with BCAS Biomedical Engineering, which it said is one of the UK's leading providers of clinical equipment services to hospitals, primary care trusts, field surgical units and emergency response providers.
Under the agreement, BCAS will market and support all of EQ2's hospital equipment management systems products exclusively in the UK.
EQ2's product line, called the HEMS Enterprise Suite, enables healthcare organizations such as hospitals and health clinics to manage their capital equipment, ranging from clinical instruments involved directly with patient care to facility equipment and systems such as HVAC, gas and electrical systems, beds and elevators.
EQ2 is a privately-held company founded in 1993 as a University of Vermont technology transfer start-up.