For the past seven years, Leadley has been employed by Boston Scientific Corp., most recently as global senior medical director, Clinical Sciences, since 2009. In 2008, she received Boston Scientific’s “Clinical Sciences Impact Award.”
“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, Leadley held positions at Advanced Stent Technologies and Pulmonx. She received her medical degree from Ludwig-Maximilian University Medical School in 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, according to the company.
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.
Based in Munich, the company's U.S. headquarters are in Wilmingto, Del.