WILMINGTON, Del. and MUNICH, Feb. 4, 2013 /PRNewswire/ -- JenaValve Technology, Inc., a privately-held, venture-backed developer, manufacturer and marketer of transcatheter-delivered aortic valve systems (TAVI) for the treatment of aortic valve disease, announced today that it has appointed veteran medical device engineering executive John F. Migliazza as Chief Operating Officer, effective February 4. Migliazza will report directly to Chief Executive Officer Helmut J. Straubinger.
Migilazza, 42, spent the past 12 years with Irvine, CA-based Edwards Lifesciences working primarily in heart valve research, engineering, manufacturing, commercial support and development. For the past three years he was Senior Director of Engineering, Heart Valve Research and Development and oversaw the research and development for global commercialization of Edwards' aortic valve, mitral valve, mitral repair annuloplasty and tricuspid repair annuloplasty devices.
"Following our initial commercial success in Europe in 2012, we are now focused on increasing the supply of our valves to match higher customer demand and launching the transfemoral version of our JenaValve device. John will play a key role in strengthening our quality and manufacturing systems and helping us navigate the regulatory process with the FDA," Straubinger said. "Given his experience at Edwards, it is clear that John is expert in heart valve technology, engineering and manufacturing. We are delighted that John recognizes JenaValve's potential to take real market share in the TAVI space and decided to join our executive team."
Previously at Edwards Lifesciences, from 2007-2008, Migliazza was Senior Director of Manufacturing, Transcatheter Heart Valve Operations where he established the manufacturing foundation for the new transcatheter heart valve business unit. He started at Edwards in 2000 as a Global Supply Chain Manager and then was promoted several times and held increasingly more manufacturing and operations titles. During this time, Migliazza was assigned to the Dominican Republic where he expanded their Caribbean plant network by establishing a stand alone operation. In 2006 he became Director of Manufacturing, Surgical Heart Valve Operations, California.
Prior to Edwards Lifesciences, Migliazza spent eight years (1992-2000) with Baxter International CVG Division.
Migliazza is a certified six sigma black belt engineer and has a bachelor's degree in business administration from California State University, Fullerton emphasizing operations and industrial management. He also has an MBA from Cal Poly Pomona.
Transcatheter aortic valve implantation systems (TAVI) have already yielded nearly $1 billion in revenues outside the United States. Analysts estimate that, to date, approximately 50,000 patients have undergone the procedure and the TAVI market, including only high-risk patients not eligible for open-heart surgery, will approach $2 billion by 2014. 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 and post-implant paravalvular leaks.
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 system is currently being sold in Europe. The Company's transfemoral system is in the final phase of development 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 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 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, Inc. and JenaValve Technology, GmbH
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 350 implantations to date. The JenaValve transfemoral aortic valve system is in the final phase of development and is expected to be completed and marketed in 2014.
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.de U.S. Contact: Matt Clawson, Allen & Caron Inc. 949.474.4300 or Matt@allencaron.com.
SOURCE JenaValve Technology, Inc.