Navigation Links
First Results Of The JUPITER Registry On Long Term Performance And Safety Of The Transapical JenaValve TAVI System
Date:5/22/2013

WILMINGTON, Del. and MUNICH, May 22, 2013 /PRNewswire/ -- JenaValve Technology, Inc., a privately-held, venture-backed developer, manufacturer and marketer of transcatheter aortic valve implantation (TAVI) systems for the treatment of aortic valve disease, announced today its first interim results of the JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere AoRtic Stenosis (JUPITER) Registry at EuroPCR in Paris. JUPITER is a post-market registry to evaluate five-year long term safety and effectiveness of the 2nd generation transapical JenaValve TAVI system in 180 elderly high-risk patients. The consecutive enrollment of the patients ensures that the patient population represents a real world clinical use of the device. All serious adverse events were source data verified. Major adverse events were adjudicated by an independent medical reviewer.

Since the first commercial implantation of TAVI systems in 2006, efforts of the manufacturers and physicians have been to further improve the handling of the devices and the clinical outcome. Device and procedural-related results including procedural success, stroke rates and paravalvular leakage are important drivers for patient safety.

With the 30-day results of the first half of the patients enrolled in the JUPITER registry, JenaValve demonstrated high procedural success rates and excellent clinical outcomes in a real world patient population with its transapical TAVI system. In 88 patients with a mean logistic EuroSCORE of 24.9 percent, the procedural success rate was 95.5 percent. Major adverse events such as major stroke (0.0 percent) or spontaneous myocardial infarction (1.3 percent) were very low and represent the safety of the JenaValve TAVI system. Excellent hemodynamics and very low paravalvular leakage (PVL) confirm the advantages of the system; 97.6 percent of the patients had a PVL <= mild, severe PVL did not occur (0.0 percent).

The data was presented by Stephan Ensminger , MD, PhD, from the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany, on behalf of the registry investigators. "The JUPITER registry confirms the excellent performance and safety of this 2nd generation TAVI system in a real world clinical use," said Dr. Ensminger.

"The very good stroke and PVL data is especially impressive. With no PVL > mild and only 2.3 percent of moderate PVL, the JenaValve TAVI system shows one of the lowest PVL rates reported in a TAVI registry," added Helmut J. Straubinger , CEO of JenaValve Technology.

About TAVI

Transcatheter aortic valve implantation systems (TAVI) have already yielded nearly $1 billion in revenues worldwide and the market is expected to grow to over $3 billion in 20161. Clinicians are now focused increasingly on TAVI technical and procedural refinements and advancements found in second-generation products such as JenaValve's which address and resolve issues including ease of implantation, the need for post-procedure pacemaker implantation and post-implant paravalvular leakage.

About the JenaValve™ TAVI System

The JenaValve is a true second-generation catheter-based aortic valve implantation system engineered and manufactured to the highest quality standards. The JenaValve transapical TAVI system is currently being sold in Europe. The Company's transfemoral TAVI system is expected to enter into clinical study later in 2013 and is anticipated to be available for sale in 2014.

  • The JenaValve prosthesis consists of a natural aortic porcine root bioprosthesis fitted with an outer porcine pericardial patch, a so-called skirt, before being sewn onto a Nitinol self-expanding stent. The high-quality bioprosthesis is durable, ensuring long-term aortic valve function.
  • JenaValve's unique "3-feeler element" allows the clinician to accurately position the prosthesis in the anatomically correct position during implantation thus ensuring a precise sub-coronary alignment within the patient's native valve.
  • JenaClip™ anchoring and clipping mechanism allows the patient's native valve leaflets to be clipped to the valve enabling the JenaValve to be firmly anchored in the correct anatomical position and provide active fixation and resistance to migration.
  • The JenaValve implantation is conducted on the beating heart. Hemodynamic flow is maintained without cardiac arrest and rapid pacing is not required during the procedure. The low profile of the stent prosthesis ensures open flow to the coronaries after the implantation. The JenaValve is available in three sizes, 23mm, 25mm and 27mm, covering aortic valve annuli from 21mm to 27mm.
  • JenaValve is retrievable and repositionable thereby contributing to a successful procedure and confidence of the clinician.

About JenaValve Technology

JenaValve Technology, Inc., domiciled in Delaware, USA with operations in Munich, Germany, develops, manufactures and markets aortic valve systems to treat patients suffering from aortic valve disease. The company's products are CE marked and its transapical aortic valve system is currently marketed in Europe with over 400 implantations to date. JenaValve is backed by world-class U.S. and European investors: Atlas Venture, Edmond de Rothschild Investment Partners, NeoMed Management, VI Partners, Sunstone Capital and GIMV. Additional information is available at www.jenavalve.com  

European Contact: JenaValve Technology GmbH, Guerickestr. 25, 80805 Munich (Germany) +498955279080 or info@jenavalve.de

U.S. Contact: Matt Clawson , Allen & Caron Inc. 949.474.4300 or Matt@allencaron.com

1)       Goldman Sachs Global Investment Research


'/>"/>
SOURCE JenaValve Technology, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics, Inc. (CTI) to Report First Quarter Financial Results on April 20
2. Thoratec Schedules First Quarter Conference Call, Webcast
3. Watson to Host Conference Call and Webcast to Discuss First Quarter 2012 Earnings
4. CVS Caremark Corporation to Hold First Quarter 2012 Conference Call
5. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
6. Alexza to Announce 2012 First Quarter Financial Results on Thursday, May 10, 2012
7. 3SBio Inc. Schedules Unaudited First Quarter 2012 Results
8. Insmed to Host 2012 First Quarter Earnings Conference Call
9. Simcere Pharmaceutical Group to Announce First Quarter 2012 Financial Results on Wednesday, May 9, 2012
10. Henry Schein to Webcast First Quarter 2012 Conference Call Tuesday, May 8, at 10:00 a.m. EDT
11. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... December 2, 2016 On Thursday, the ... the Dow Jones Industrial Average edged 0.36% higher, to finish ... 0.35%. Losses were broad based as six out of nine ... research reports on the following Services equities: Myriad Genetics Inc. ... QGEN ), INC Research Holdings Inc. (NASDAQ: INCR ...
(Date:12/2/2016)... 2016 The concept of rare diseases and the ... this sector has been taking shape in Europe ... aspects and initiatives related to orphan medicinal products have been ... of member states individually. Many member states in the EU ... of orphan medicinal products, the result of which took the ...
(Date:12/2/2016)... 1, 2016 Around the corners of world, ... each habitable land present over earth. Cancer has become ... in a life time this is because of the ... now. Given the steady increase in global cancer incidence ... spiraling healthcare costs of treatment, there is increasing interest ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... ... Lori G. Cohen and Sara K. Thompson , shareholders ... American Conference Institute’s 21st Drug & Medical Device Litigation Conference , taking place in ... , Cohen, who chairs the firm’s Pharmaceutical, Medical Device & Health Care Litigation Practice ...
(Date:12/2/2016)... ... ... over twenty-four years, Doctors on Liens has published a directory of the top ... care. When the company started in 1997, the directory was a single page focusing ... now ten-page directory features a vast array of medical specialists stretching from Sacramento ...
(Date:12/2/2016)... California (PRWEB) , ... December 02, 2016 , ... ... professionals, proudly announces the launch of its 60-day free trial program for all ... trip shipping make the offer a truly hassle free experience. , FlexiSpot’s unique ...
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... U.S. Surgeon ... interview with Mediaplanet, Dr. Murthy explains how he was inspired to practice medicine at ... learned that medicine is about more than making diagnoses and prescribing medicine,” he states. ...
(Date:12/2/2016)... ... December 02, 2016 , ... ... Hills, California, will be included in the 2016 “Guide to America’s Top Plastic ... based on the amalgamation of their education, experience, and professional associations. , ...
Breaking Medicine News(10 mins):