Navigation Links
NeuroVasx Receives FDA Approval for cPAX Aneurysm Treatment System
Date:4/5/2011

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.

(Logo: http://photos.prnewswire.com/prnh/20110405/CG77724LOGO)

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. (www.neurovasx.com) 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:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... PALO ALTO, Calif. , Feb. 8, 2016 ... chemical manufacturing, and Kodiak Sciences Inc., a biopharmaceutical company ... retinal disease, announced today agreements for the clinical supply ... manufacture material at multiple sites, including Slough (UK), Visp ... --> Retinal diseases, such as age-related ...
(Date:2/8/2016)... N.C. , Feb. 8, 2016  Avista Pharma ... Eric Setzer as Chief Financial Officer (CFO). Mr. ... twenty years of experience in various roles within growing ... Pharma, he served as the Executive Director of Finance ... in Raleigh, NC . Previously, Mr. ...
(Date:2/8/2016)... Vestagen Technical Textiles, Inc., a medical technology ... and other demanding applications, today announced it has named ... Dale Pfost , PhD, who was serving as ... joining Vestagen,s Board of Directors. ® , ... technologies that combines fluid repellent, antimicrobial and breathability properties. ...
Breaking Medicine Technology:
(Date:2/8/2016)... MD (PRWEB) , ... February 08, 2016 , ... ... is excited to share this important news! AHCC and the Home Health and ... Coding Clinic, CMS' designee for official ICD coding guidance and clarifications, to address ...
(Date:2/8/2016)... ... 2016 , ... The schedule is now online for the largest ... which is being held May 25-29 at the Loews Chicago O’Hare Hotel, continues to ... causes of chronic illness in children. , Very recent articles have cited 1 child ...
(Date:2/7/2016)... ... 2016 , ... HealthSmart Holdings, Inc. announced today the launch ... and information to lower the costs, and increase the impact of their healthcare ... healthcare benefits by as much as 22%:, + Price and quality transparency, ...
(Date:2/6/2016)... ... ... With the FCPX LUT: Summer pack from Pixel Film Studios, ... is a Lookup Table that contains a mathematical formula for modifying an image. The ... manipulating each pixel, LUT's can change each color range differently, it gives the user ...
(Date:2/5/2016)... ... February 05, 2016 , ... Love is in the ... a variety of colors, assortments and packaging. This staple for Valentine’s Day is a ... location. , For Valentine’s Day, not only are long-stem roses available, but also ...
Breaking Medicine News(10 mins):