ALISO VIEJO, Calif., Oct. 21 /PRNewswire/ -- MicroVention, Inc., a private company dedicated to the development and commercialization of new technologies for the endovascular treatment of cerebral aneurysms, announced today the launch of a 500-patient independent, international study of its HydroCoil Embolization System for treating brain aneurysms. The prospective, randomized study will feature a direct comparison between the results derived from the HydroCoil system to results from bare platinum coils which are currently the mainstay of endovascular aneurysm therapy.
The head-to-head study, titled HydroCoil: Endovascular Aneurysm Occlusion and Packing Study (HELPS), is based in the United Kingdom, sponsored in the UK by Lothian Health and supported by the UK's National Health Service. Physicians in the U.S., France and Germany are also participating in the study.
"HELPS was instigated by physicians who have also designed its protocol and are running the trial," said Philip White, M.D., of Western General Hospital in Edinburgh who is the chief investigator. "Based on our experience with HydroCoil, we believe it may provide an improvement in the long-term effectiveness of endovascular treatment because of its ability to more completely fill cerebral aneurysms; however, a trial like HELPS is needed to confirm this," Dr. White said.
A cerebral aneurysm is a potentially deadly bulge or sac in the wall of an artery in the brain. "Physicians traditionally have used bare platinum coils to promote clotting of the aneurysm and prevent it from rupturing," said Mike Kleine, President and CEO of MicroVention. "However, previous retrospective studies and clinical experience have shown the HydroCoil system, which employs an expandable device that allows physicians improved volumetric filling and stability, is more effective."
HydroCoil is a second-generation endovascular coil that was launched in late 2002. It is designed to combine the features of greater space filling and improved healing of a microporous expandable hydrogel with the delivery and handling characteristics of a detachable platinum coil, Kleine added.
"We are confident enough with this technology to take the lead in the market and test our product head-to-head against bare platinum coils," Kleine said. "We believe this independent, multi-center study using hydrogel technology will validate the superiority of HydroCoil to platinum coils because of its ability to more effectively treat a broad range of cerebral aneurysms."
About the HES Procedure
The HydroCoil Embolic System is a unique endovascular embolization device combining the company's platinum microcoil technology with a proprietary, highly expandable microporous hydrogel called Intelligel. Intelligel is a responsive or "smart biomaterial" that does not swell until a period of contact with blood. This responsiveness gives physicians the ability to precisely control delivery of the device and allows for repositioning if necessary. When the hydrogel swells, it provides improved filling of the aneurysm. HydroCoil combines the safety and ease of use of platinum coils with the filling and mechanical stability properties of the hydrogel. HydroCoil offers a new therapeutic alternative to the current treatment choices of platinum coil embolization and neurosurgical clipping. HydroCoil is also being used clinically to treat fistula and peripheral vascular aneurysms.
About MicroVention, Inc.
MicroVention, Inc. (http://www.microvention.com/) is a privately held medical-device company dedicated to the development and commercialization of new catheter-based technologies for the endovascular treatment of peripheral and cerebral vascular diseases. The company has received 510(k) clearance and CE Mark for both its MicroPlex Coil and HydroCoil Embolization Systems to treat cerebral aneurysms. MicroVention sells its products through its direct sales force in the U.S., Canada, France, Germany and the United Kingdom and through distributors in various other countries.
CONTACT: Michael Kleine, President, CEO, or William Hughes, VicePresident, CFO, both of MicroVention, +1-949-461-3314, or fax,+1-949-461-3329; or Media, Matt Clawson of Allen & Caron, Inc.,+1-949-474-4300, or fax, +1-949-474-4330, for MicroVention, Inc.