Navigation Links
Surgeons Complete Clinical Trial on Novel Two-Part Heart Valve
Date:6/11/2013

Denver, Colo., (PRWEB) June 11, 2013

Surgeons in Europe have completed clinical trials on the world’s first serviceable bioprosthetic heart valve, paving the way for the CE mark and commercial sale of an advanced heart valve that eliminates many common problems for cardiac valve patients.

Cardiac surgeons in Germany, Austria and Poland have successfully completed implants and patient enrollment in the VITAL-2 clinical trial for the Vitality Heart Valve System™ from ValveXchange, Inc. The system incorporates a two-piece heart valve and allows a simple two-step implant procedure that provides excellent visibility into the aortic chamber, according to John Parrish, chairman and CEO of ValveXchange. The valve enables the smaller incisions that patients are now demanding. The design of the valve also allows a surgeon to replace just the leaflet set later in life, without having to completely explant and remove the entire valve.

By resolving conflicts between conventional mechanical and tissue-based prosthetic values, the Vitality system eliminates patients’ need for complex future open-heart surgeries and high doses of anti-coagulation drugs. Currently, adult patients require repeated open-heart surgeries, as they typically receive tissue valves that wear out every 10-15 years. Younger and physically active patients often receive mechanical heart valves that do not wear out, but require lifelong high doses of anti-coagulation drugs that force a sedentary lifestyle with serious side effects.

The completion of the implants, and patient enrollment places ValveXchange on track to obtain a CE mark for the system later this year. At that point, ValveXchange will release the product for commercial sale in the European Union and in other regions of the world recognizing the CE mark. The CE mark indicates a product's compliance with European Union requirements, and enables the free movement of products within the European Economic Area. ValveXchange will also implement the process for FDA clearance in the United States.

“This milestone represents a major achievement for ValveXchange,” says Parrish. “The completion of enrollment in the VITAL-2 trial, and the best-in-class valve performance results, substantiate the ValveXchange philosophy that better science equals better valves.”

Vitality Heart Valve System
The ValveXchange system includes a two-part valve with a permanently implanted base and an easily replaceable leaflet set. Surgeons can replace the leaflet set transapically (through the apex of the heart), accessing it by a small incision between the ribs. The system’s design allows surgeons to replace leaflets with standard, minimally invasive surgical techniques that are faster and simpler than traditional redo valve replacement surgeries, while restoring top performance at the same time.

ValveXchange heart valves provide excellent hemodynamics, long durability and leaflet exchangeability, and are easy to implant, according to Ivan Vesely, Ph.D., heart valve scientist and founder of ValveXchange. “The Vitality Heart Valve System offers simplicity, security and unprecedented visibility into the aortic space,” he says. “The hemodynamics of the Vitality valves – are excellent, particularly in the smaller valve sizes.”

ValveXchange®, Inc. (http://www.valvexchange.com)
ValveXchange®, Inc. is an emerging medical technology company serving cardiac surgeons and cardiologists. The company is the developer of the Vitality Heart Valve System™, the first serviceable bioprosthetic heart valve. The company’s family of products also includes the Vitality-S™ sutureless valve, ideal for minimally invasive and robotic implants, and ValveXchange Vanguard™ transcatheter valves for the inoperable patient. All of the valves are serviceable for leaflet replacement later in life.

Based in Denver, ValveXchange holds 13 patents and has an additional 8 patent applications in process. The company’s research has been supported in part by $4 million in grants from the National Institutes of Health.

Read the full story at http://www.prweb.com/releases/2013/6/prweb10820099.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. Reputable Surgeons Should Reject Some Prospective LASIK Patients
2. Johns Hopkins surgeons among the first in the country to perform a robotic single-site hysterectomy
3. JD Media Surge, LLC Launches New Blog to Help Cosmetic Surgeons Attract More New Patients from the Internet
4. Greenville Oral & Maxillofacial Surgeons Announce CPR Re-Certification
5. JD Media Surge's CosmeticSurgeonsOnline.com Voted #1 Source for Plastic Surgery SEO
6. The Surgeons of Los Angeles Colon and Rectal Surgical Associates are Now Offering Exparel for Use in Local Anesthesia During Anorectal Operations
7. 13-Year-Old Girl with Rare Tumor Thanks Surgeons at North Shore-LIJ's Cohen Children's Medical Cener
8. US News & World Report Recognizes Dr. Rod J. Rohrich in Top 1% of Country's Top Plastic Surgeons
9. Many plastic surgeons view social media as important tool for promoting their practice
10. Dr. Jeffrey M. Kenkel Selected Among Top 1% of Plastic Surgeons by US News & World Report
11. Plastic Surgery Website Design Services Launched By JD Media Surge, LLC Helps Plastic Surgeons Get More New Surgery Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/20/2017)... BATON ROUGE, La. (PRWEB) , ... July 20, 2017 , ... ... Surgeon, to the staff. Dr. Dunbar received his BS in Biology from LSU, graduating ... was the Medical School Class President. After his residency in St. Louis, Dr. Dunbar ...
(Date:7/20/2017)... ... July 20, 2017 , ... The Business ... Body of Knowledge (BIZBOK® Guide )v 6.0 is now available for member download. ... through Guild collaborative teams. , Non-members may download the Part 1 Introduction ...
(Date:7/20/2017)... (PRWEB) , ... July 20, 2017 , ... LINET, an ... latest innovation to their product line: the AVE 2 birthing bed. , Perfectly suitable ... bring a new level of comfort and efficiency to every phase of childbirth. The ...
(Date:7/20/2017)... ... 2017 , ... At Creekwood Dental Arts, Drs. Donna G. Miller and Michelle ... dental implants in Waco, TX, using the latest dental technology for digital imagery ... can capture details in the oral cavity for accurate diagnoses and customized care plans. ...
(Date:7/20/2017)... ... July 19, 2017 , ... ... senior healthcare project manager, Josh Christensen. As a leader in healthcare construction, AP ... further its healthcare resume in the Midwest with Josh now on board. ...
Breaking Medicine News(10 mins):
(Date:7/10/2017)... CLEVELAND , July 10, 2017  US medical ... billion in 2021, according to Medical Equipment ... released by Freedonia Focus Reports. Continued increases in demand ... the aging of the population and supported by gains ... associated equipment and supplies. New product introductions will also ...
(Date:7/10/2017)... 2017  BDI Group subsidiary Pathway Purchasing Network, ... organization serving specialty pharmacies, home infusion companies and ... significant, value-added member programs designed to help organizations ... and improve access and affordability for patients who ... Pathway has worked ...
(Date:7/10/2017)... RESEARCH TRIANGLE PARK, N.C. , July 10, 2017 ... of a $5m Convertible Note to support the development ... led by Tencent Holdings Limited, a leading Chinese Internet ... Center. This funding will advance multiple infectious disease product ... Founded by Dr. ...
Breaking Medicine Technology: