Navigation Links
NeuroVasx Receives FDA Approval for cPAX Aneurysm Treatment System

MAPLE GROVE, Minn., April 5, 2011 /PRNewswire/ -- NeuroVasx announced today that the FDA has approved the cPAX Aneurysm Treatment System as a Humanitarian Use Device (HDE) for the treatment of large, giant and wide-neck cerebral aneurysms, which are typically the most difficult to treat.  The HDE allows for the treatment of up to 4,000 patients per year in the U.S.


Christopher Dowd, M.D., Clinical Professor of Neuro-Interventional Radiology at the University of California at San Francisco and Medical Director for NeuroVasx, Inc., said, "The large, giant and wide-neck cerebral aneurysm population continues to remain the most challenging to treat.  cPAX will offer physicians an alternative solution that we believe can make a significant impact in treatment and outcome for these patients."  Ricardo Hanel, M.D., PhD, Associate Professor of Neurosurgery at the Mayo Clinic in Jacksonville, Florida and Co-Principal Investigator in the cPAX Clinical Trial, states, "The longer term stability we have seen in the clinical studies using cPAX in larger aneurysms gives me great confidence in the positive impact this product will have on the care of our patients."

A cerebral aneurysm is an abnormal bulge or sac in the wall of an artery in the brain which can be caused by a number of factors including congenital defects, high blood pressure, atherosclerosis, cancer, drug use or head trauma.  If a cerebral aneurysm ruptures, it can lead to a hemorrhagic stroke, or bleeding on the brain.  According to the National Institutes of Health, approximately 40% of these patients do not survive the first 24 hours.  The worldwide incidence of cerebral aneurysms is estimated to be 320,000 annually, approximately 200,000 of which may be treatable with intracranial surgery using minimally invasive techniques.  

cPAX is a polymeric strand delivered into the aneurysm using a technique similar to currently available platinum coil technologies.  cPAX, because of its soft polymeric material, is designed to achieve more complete filling of the aneurysm with the probable benefit of greater long term stability.  A significant feature of cPAX in comparison to currently available technologies is that it offers the physician the ability to detach the device at any point versus a fixed detachment zone common in platinum coils.  The polymeric material also allows for non-invasive CT and MRI scans with little or no artifact for more accurate patient follow-up assessment.

Eric B. Timko, President and CEO of NeuroVasx, said, "This FDA approval brings an important cutting-edge technology to a patient population that is currently underserved.  We are excited to offer this treatment to patients and we look forward to working with our key physicians to bring this product to market."

About NeuroVasx, Inc.

NeuroVasx, Inc. ( is a privately held medical device company located in Maple Grove, MN. The company is dedicated to the development and commercialization of technologies for the minimally invasive treatment of hemorrhagic and ischemic stroke.  The worldwide market potential for stroke treatment devices is estimated to be over $3 billion.

SOURCE NeuroVasx, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. NeuroVasx, Inc. Announces $8.5 Million Private Placement and Completion of cPAX Aneurysm Treatment Study
2. superDimension Receives FDA 510(k) Clearance for Marker Delivery Kit
3. Mylan Receives Approval for Generic Version of Xalatan® Ophthalmic Solution
4. Nile Therapeutics Receives Fast Track Designation for Cenderitide for Post-Acute Indication
5. Senate Receives Rx Blueprint Plan That Reduces Spending and Increases Quality
6. CarePoint Partners Receives Louisiana Dietetic Association Corporate Award
7. Adeonas Multiple Sclerosis Trial Receives $409,426 Grant
8. HeartWare International Receives Approval From the Therapeutic Goods Administration (TGA) in Australia
9. Boston Scientific Receives FDA Approval of New Clik(TM) Anchor for Precision Plus(TM) Spinal Cord Stimulator System
10. Qualitest Receives FDA Approval for Toresmide Tablets (Generic Demadex®) 5 mg, 10 mg, 20 mg, 100 mg, for the Treatment of Edema Associated with Congestive Heart Failure, Renal Disease, or Hepatic Disease
11. Actavis Receives Approval of Valacyclovir Hydrochloride Tablets in the U.S.
Post Your Comments:
(Date:11/24/2015)... , Nov. 24, 2015   HeartWare International, Inc ... less-invasive, miniaturized circulatory support technologies that are revolutionizing the ... and Chief Executive Officer Doug Godshall is ... Annual Healthcare Conference on December 1, 2015 at ... 1-2 in New York . ...
(Date:11/24/2015)... 24, 2015  Ascendant Solutions, Inc. (Pink Sheets: ASDS ... of Directors has declared a special 1 percent stock dividend ... payable December 14, 2015, to shareholders of record December 7, ... additional shares of common stock. --> ... a strong endorsement of our confidence in Ascendant,s growth strategy ...
(Date:11/24/2015)... Nov. 24, 2015  Figure 1, a free mobile-first ... medical cases, has launched a new completely redesigned web ... version allows radiologists, who work primarily on a desktop, ... engage with its radiologist user base, Figure 1 is ... North America (RSNA) Annual Meeting. ...
Breaking Medicine Technology:
(Date:11/24/2015)... City, UT (PRWEB) , ... November 24, 2015 , ... ... Forbes Magazine. For a business, it is critical that the first impression be positive ... business, they are not likely to buy anything or want to return. They will ...
(Date:11/24/2015)... ... 2015 , ... In response to recent news highlighting Oxycodone fraud, Novus Medical ... the United States grew 400 percent between 1999 and 2010, far more than the ... percent of all fatal drug overdoses. (1) , While oxycodone and the extended release ...
(Date:11/24/2015)... ... November 24, 2015 , ... The American Association ... their local poison centers through donations on Tuesday, Dec. 1, 2015. Since 2012, ... day that inspires people to collaborate in improving their local communities and help ...
(Date:11/24/2015)... ... 24, 2015 , ... With Thanksgiving right around the corner, holiday travel season ... protect your family and vehicle. , According to the National Highway Traffic Safety Administration, ... is sharing the following safety tips from the NHTSA: , ...
(Date:11/24/2015)... ... November 24, 2015 , ... Abington Hospital ... Aetna Institute of Quality® Bariatric Surgery Facility for treating individuals living with morbid ... health care services available to its members to help them make informed decisions ...
Breaking Medicine News(10 mins):