“Dr. Leadley has attained great success in the execution of clinical development plans and regulatory strategies that achieve product approval and market introduction of new medical therapies.” said Helmut J. Straubinger, CEO. “Her appointment underscores our conviction that JenaValve will begin commercialization of its second-generation TAVI system, designed to provide greater safety and improved outcomes for heart valve patients who are unsuitable for conventional open-heart surgery.”
Prior to Boston Scientific, Dr. Leadley held positions at Advanced Stent Technologies (Director, Clinical Affairs) and Pulmonx (Director, Clinical Research). She received her Medical Doctor degree from Ludwig-Maximilian University Medical School (Munich, Germany) in 1989. She is fluent in English and German.
JenaValve is in the midst of a multicenter CE-mark pivotal trial to evaluate the safety and efficacy of its transapical TAVI system for teams of cardiac surgeons and interventional cardiologists. Aortic stenosis, the most prevalent heart valve disease in Western countries, is increasing steadily with an aging population. The decision to surgically replace a diseased aortic valve is problematic in some elderly patients due to associated high mortality and morbidity risks. In fact, elderly patients with severe aortic disease symptoms are not often considered candidates for surgery.
JenaValve’s advanced TAVI systems are designed for this cohort of patients. JenaValve’s second-generation transapical TAVIsystem is designed to enable correct positioning, re-positioning and retrieving to ensure patient safety and procedural efficacy. In addition, the company’s TAVI system is designed to reduce the long learning curve associated with TAVI devices now used by physicians.
About JenaValve Technology
JenaValve Technology is a medical device company focused on developing transcatheter valve implantation systems to treat patients suffering from aortic valve disease. The company has transcatheter aortic valve implantation (TAVI) systems for both transapical and transfemoral approaches to address the needs of the cardiac surgeon and cardiologist, respectively. JenaValve’s investors include: Atlas Venture, Edmond de Rothschild Investment Partners (EdRIP), NeoMed Management, VI Partners, Sunstone Capital and Gimv NV.
JenaValve and JenaClip are trademarks of JenaValve Technology GmbH. The JenaValve products are protected by pending and granted patent, design and utility model rights.
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