Navigation Links
Nfocus Neuromedical Announces FDA 510(k) Clearance for Next Generation Device to Treat Vascular Lesions

PALO ALTO, Calif., Jan. 11, 2011 /PRNewswire/ -- Nfocus Neuromedical, Inc., an innovative medical device company with a focus on the next generation treatment for brain aneurysms, today announced that the company received U.S. Food and Drug Administration 510(k) clearance for its Acta™ Vessel Occlusion System (VOS).  The Acta VOS provides physicians with a minimally-invasive alternative to current treatment options for an array of common and potentially serious vascular lesions.

The Acta VOS is designed to occlude (close) targeted veins and arteries with great precision. Vascular occlusion is often used to block blood flow to malformed, weakened or leaking vessels, or to benign or malignant tumors.

"The Acta VOS and the Nfocus technology platform on which it's based address an important and, to this date, insufficiently resolved medical need," said Eric Milledge, chairman and CEO, Nfocus Neuromedical.  "The Acta 510(k) clearance is a tangible demonstration of our company's progress and is the first step toward clearance of the Nfocus platform of braided occluders, which includes the Luna™, our flagship product for treating brain aneurysms."

Vascular occlusions were historically accomplished by surgically closing the targeted blood vessel – a traumatic and expensive procedure. More recently, surgeons began placing small wire coils and other vascular plugs through catheters to stop blood from flowing to the area of concern. However, several coils may be required to occlude a single vessel, and occlusions frequently re-open. Pre-clinical studies demonstrate that the Acta VOS stops blood flow in a vessel more quickly and durably than both coils and a predicate plug device.

The Acta VOS uses a self-expandable, multi-layer oval implant made from Nitinol, a nickel-titanium alloy. Nitinol's properties allow the device to easily compress within a conventional catheter, and then rapidly open to full size once deployed within a vessel.  The Acta VOS is mounted on an elegant delivery system that allows physicians to easily retract and reposition the device.  Once the device is deployed and the desired location is achieved, a single lever detaches the Acta VOS, leaving it behind to occlude blood flow.  

"The FDA has rigorous requirements for embolization devices such as the Acta VOS," said Robert O'Holla, vice president of regulatory affairs, Nfocus Neuromedical.  "This 510(k) clearance provides strong validation for both our technology platform and development approach."

About Nfocus Neuromedical, Inc.

Nfocus is developing the next generation treatment for brain aneurysms. The company's innovative LUNA™ product is a single-deployment, easy-to-use embolization device designed to be a direct replacement to detachable coils. Nfocus is backed by three major U.S. and OUS-based venture funds: DFJ ePlanet Capital, Technology Partners, and InCube Ventures. Other investors include Raffles Capital and Endeavor Vision. More information can be found at  

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

Related medicine technology :

1. Dehaier Medical Announces Participation in Arab Health 2011
2. CareFusion Announces Sale of OnSite Services Instrument Management and Repair Business
3. BD Announces Live Webcast of First Fiscal Quarter Earnings Conference Call
4. Stereotaxis Announces CE Mark and First Human Case for Vdrive™
5. AccessClosure Announces Launch of New Mynx Cadence™ Vascular Closure Device
6. STAAR Surgical Announces Fourth Quarter 2010 Revenue Expected to Exceed $14.2 Million
7. Mithridion, Inc. Announces New Funding and Outlines Strategy for Central Nervous System Drug Development
8. Nalco Announces Price Increase
9. Vasomedical Announces Launch of Its Online Company Store
10. Mindray Medical Announces Preliminary 2010 Operating Results
11. Mindray Medical Meets 2010 Product Development Targets and Announces Strong 2011 Pipeline
Post Your Comments:
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... report to their offering. ... failure, it replaces the function of kidneys by removing the ... the treatment helps to keep the patient body,s electrolytes such ... Increasing number of ESRD patients & substantial healthcare expenditure on ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in ... ways they remain in the eye of the beholder, according to experts who offered ... The American Journal of Managed Care. For the full issue, click here . ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is ... a fitness app. The fitness app plans to fix the two major problems leading the ... one size fits all type program , They don’t eliminate all the reasons ...
(Date:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
Breaking Medicine News(10 mins):