Navigation Links
ev3 Inc. Receives FDA Clearance to Market EverCross and NanoCross Peripheral Angioplasty Balloons
Date:12/9/2008

PLYMOUTH, Minn., Dec. 9 /PRNewswire-FirstCall/ -- ev3 Inc. (Nasdaq: EVVV), a global endovascular device company, announced today that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its EverCross 0.035" and NanoCross 0.014" peripheral angioplasty balloon catheters. ev3 expects to begin full commercialization of the EverCross and NanoCross peripheral balloon catheters globally in January 2009.

Robert Palmisano, ev3's president and chief executive officer commented, "We are looking forward to launching the EverCross and NanoCross balloons this January. Based on our experience to date, we believe both balloons will enhance customer ease of use and offer significantly better margins than our current distributed product. The ability to offer our own peripheral balloon catheter also provides access to key international markets, including Europe, where we do not currently sell balloons."

The EverCross and NanoCross peripheral balloon catheters are designed to offer improved overall performance in peripheral angioplasty procedures. Among several new features, both catheters offer innovative beveled tip profiles for best-in-class lesion entry and a broad range of sizes, including the only 200 mm length .035" balloon available worldwide. The EverCross balloons also offer Rated Burst Pressures that compete in the high pressure balloon market without compromising ease of use.

About ev3 Inc.

Since its founding in 2000, ev3 has been dedicated to developing innovative, breakthrough and clinically proven technologies and solutions for the treatment of peripheral vascular and neurovascular diseases. ev3's products are used by endovascular specialists to treat a wide range of peripheral vascular and neurovascular diseases and disorders. The company offers a comprehensive portfolio of treatment options, including the primary interventional technologies used today -- peripheral angioplasty balloons, stents, plaque excision systems, embolic protection devices, liquid embolics, embolization coils, thrombectomy catheters and occlusion balloons. More information about the company and its products can be found at http://www.ev3.net.

ev3, the ev3 logo, EverCross and NanoCross are trademarks of ev3 Inc., registered in the U.S. and other countries.

Forward-Looking Statements

Statements contained in this press release that relate to future, not past, events are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements often can be identified by words such as "expect," "anticipate," "intend," "will," "may," "believe," "could," "continue," "future," "looking forward" or the negative of these words or other words of similar meaning. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause ev3's actual results to be materially different than those expressed in or implied by ev3's forward-looking statements in this release. For ev3, such particular uncertainties and risks include, among others, the timing of the introduction of new products, the success and market acceptance of new products, impact of competitive products and pricing, regulatory risks, availability of third party reimbursement and ev3's future operating results and financial performance. More detailed information on these and additional factors that could affect ev3's actual results are described in ev3's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Except as required by law, ev3 undertakes no obligation to update publicly its forward-looking statements.


'/>"/>
SOURCE ev3 Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Kuvan Receives Marketing Approval in the European Union
2. Align Technology Receives Expanded Regulatory Approval in Japan
3. Adecco Receives Honor From Alcon Laboratories
4. ANA598 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C Infection
5. EastMed Inc. receives FDA clearance to market uresta(TM) in the U.S.
6. SuperGen Receives Clearance to Begin Clinical Trials With SGI-1776, a PIM Inhibitor
7. Serica Technologies Receives ISO Certification, Meets International Standards for Medical Device Manufacturing
8. Bavarian Nordic Receives USD 25 Million Milestone Payment After Submission of Important IMVAMUNE(R) Data to The U.S. Health Authorities
9. Cellectricon Receives Milestone Order for Cellaxess(R)HT, the Worlds First High Throughput RNAi Screening System
10. China Medical Technologies Receives SFDA Approval for Breast Cancer HER-2 FISH Probe
11. West Michigans Newest Medical Device Company Receives Support from the West Michigan Science & Technology Initiative and EDF Ventures
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2017)... ... ... Bacterial biofilms, surface adherent communities of bacteria that are encased in a ... and catheter infections to gum disease and the rejection of medical implants. Though ... year, there is currently a paucity of means for preventing their formation or treating ...
(Date:5/22/2017)... ... May 22, 2017 , ... ... it is exhibiting in booth B2 at the Association for Pathology Informatics ... , In addition to demonstrating its Cancer Diagnostic Cockpit and Consultation Portal, ...
(Date:5/18/2017)... ... May 18, 2017 , ... Dr. ... 2017 at the Prince Of Wales Private Hospital. The procedure was performed on ... The patient failed conservative treatments prior to undergoing surgery. , The AxioMed viscoelastic ...
(Date:5/18/2017)... Massachusetts (PRWEB) , ... May 17, 2017 , ... ... company specializing in medical device compliance and commercialization, has just released version 9.0 ... of work into this latest version of Cockpit,” says David Cronin, CEO of ...
Breaking Biology Technology:
(Date:3/30/2017)... , March 30, 2017 The research team ... for three-dimensional (3D) fingerprint identification by adopting ground breaking 3D fingerprint ... new realm of speed and accuracy for use in identification, crime ... affordable cost. ... A ...
(Date:3/27/2017)... , March 27, 2017  Catholic Health Services ... Management Systems Society (HIMSS) Analytics for achieving Stage ... Model sm . In addition, CHS previously earned ... hospitals using an electronic medical record (EMR). ... high level of EMR usage in an outpatient ...
(Date:3/23/2017)... Mar. 23, 2017 Research and Markets has ... Analysis & Trends - Industry Forecast to 2025" report to ... ... a CAGR of around 8.8% over the next decade to reach ... analyzes the market estimates and forecasts for all the given segments ...
Breaking Biology News(10 mins):