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:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... June ... about the dangers associated with chronic pain and the benefits of holistic treatments, ... individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of ... AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Roche (SIX: RO, ROG; OTCQX: ... its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated ... shock. With this clearance, Roche is the first IVD ... solution for sepsis risk assessment and management. ... and PCT levels in blood can aid clinicians in ...
(Date:6/23/2016)... , June 23, 2016 , ... on Thursday, July 7, 2016 , , , , LOCATION: ... , , , , EXPERT PANELISTS:  , , , ... Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and ... The global pharmaceutical industry is witnessing an exceptional era. ...
(Date:6/23/2016)... June 23, 2016 The vast majority of ... dialysis facility.  Treatments are usually 3 times a week, ... visit, including travel time, equipment preparation and wait time. ... especially grueling for patients who are elderly and frail.  ... nursing and rehabilitation centers for some duration of time. ...
Breaking Medicine Technology: