A Medical Device Daily
The emerging market for neurovascular embolectomy devices for the treatment of acute ischemic stroke is poised for healthy yet conservative growth of close to 15% annually in Europe over the next five years, according to a report from Millennium Research Group (MRG; Waltham, Massachusetts).
MRG's European Markets for Clot Management Devices 2009 report finds that although clinical safety data available to date has been positive for neurovascular embolectomy devices, more conclusive data is needed before widespread adoption occurs. Furthermore, as of mid-2009, reimbursement for neurovascular embolectomy procedures was limited in Europe.
Because infarcted brain tissue dies within minutes, early treatment is critical. Neurovascular embolectomy devices – including Concentric Medical's (Mountain View, California) MERCI Retriever, the Penumbra System and the Phenox Clot Retriever – extend the window of time for therapeutic intervention beyond the conventional three hours following onset of stroke symptoms approved for treatment with intravenous recombinant tissue plasminogen activator (IV rt-PA). This is noteworthy given the fact that most patients with suspected stroke in Europe arrive at the emergency department after the three-hour time window. In addition, these devices provide a treatment alternative to patients in whom conventional thrombolysis might be ineffective or contraindicated.
"Despite satisfying unmet needs in acute ischemic stroke treatment, physician conservatism over these devices will continue to limit device adoption in Europe through 2013," said Darren Navarro, senior analyst at MRG. "Physicians seem to feel that although clinical results have been positive with respect to the safety and efficacy of cerebral revascularization, more conclusive data is needed demonstrating the beneficial effects of these devices on patient outcomes."
Invatec reports availability of REEF HP
Invatec (Lisbon, Portugal) reported the availability of REEF HP, a PTA Balloon Catheter, ideal for use in all peripheral high pressure dilatation procedures. The lesion-specific design of the balloon material is particularly useful in hard-to-dilate situations and the availability of variable shaft lengths mean that the Reef HP is equally suited to both arteriovenous shunts and peripheral applications.
The REEF HP balloon is made from Invatec's Flexitec XF, a material with a large working pressure range, offering control during high pressure procedures. It is also a low compliant balloon, offering a uniform dilatation force and strong shape retention to dilate resistive lesions with greater success and extreme stability.
The company also reported launch of its self-expanding peripheral stent system, Maris Plus. The Maris Plus stent has a lesion-specific design with larger sizes to meet the clinical requirements of the iliac region. The Maris Plus becomes the sixth stent platform now marketed by Invatec for the treatment of peripheral arterial disease.
Boston Scientific releases iLab System Software
Boston Scientific (Natick, Massachusetts) has released its CE-marked iLab System Software for the iLab Ultrasound Imaging System. Intravascular ultrasound technology is designed to provide physicians a 360-degree view inside the heart and coronary vessels to assist with diagnosis and to allow a more accurate representation of the diseased vessels than is possible with angiography alone. The iLab software upgrade includes functionality designed to improve diagnosis and save time. The principal new feature of the system, iMap, provides a detailed color analysis of plaque composition within the targeted areas.
Occlutech defeats injunction request in Spain
Occlutech (Zurich) said that, together with its partner Izasa (Barcelona), it defeated a request for an injunction against sales and marketing activities in Spain, launched at the Commercial Court I of Barcelona, Spain by its U.S. competitor AGA Medical (Plymouth, Minnesota).
The request by AGA was based on alleged patent infringement and unfair competition claims related to wrongful assumptions and misleading statements about the outcome of a recent ruling by the patent court in Dusseldorf and about Occlutech.
The court came to the conclusion that Occlutech's products offered for sale by Izasa do not infringe patent EP0808138 held by AGA in Spain that is Europe's fifth largest market.
In October 2008 Occlutech won against AGA Medical in the District Court of The Hague. In December 2008 the Higher Regional appeal Court in Dusseldorf, that has no jurisdiction over sales by Occlutech's partners outside of Germany, decided against Occlutech. In July, however, the Patents Court of the High Court of Justice, London declared that Occlutech's products are not infringing AGA's patent EP 0808138.