Kips Bay Medical, Inc. (KIPS) announced on August 22nd/2012 that its U.S. feasibility trial (eMESH I) of the eSVS Mesh has commenced in Bern, Switzerland and anticipates first implants and enrollments under this study to begin the week of September 2, 2012.
The objective of the eMESH I study remains the demonstration of initial safety and performance of the Kips Bay Medical eSVS Mesh sufficient to allow the FDA to approve an IDE for a pivotal study.
Also, KIPS has begun the process of responding to the FDA disapproval of its most recent IDE Application received on August 17, 2012.
Kips Bay Medical is gathering the necessary information and will provide it to the FDA within 30 days in an amended IDE Application.
Manny Villafaña, Kips Bay Medical Founder, commented:
Despite the FDA response, we have received a significant level of interest and excitement about our eSVS Mesh by several leading U.S. cardiac surgeons who we recently introduced the product to in anticipation of a potential study here in the U.S. Their high level of interest in and eagerness to study the eSVS Mesh is a tremendous motivator for me, and the Kips Bay team, to ensure that the clinical study of the eSVS Mesh is performed properly in both the U.S. and Europe.
Mr. Villafaña founded Cardiac Pacemakers, Inc. (CPI), a CRM company that revolutionized the pacemaker industry by introducing a long life lithium iodine pacemaker, a technology still utilized today by 100% of the market. CPI was ultimately acquired by Eli Lilly & Company, which spun out CPI as Guidant, which in turn was recently acquired by Boston Scientific, Inc. After CPI, Manny founded St. Jude Medical, Inc. Manny led St. Jude Medical’s development of a novel heart valve that still dominates the mechanical valve replacement market. Manny has also founded and led the public offering for medical technology companies such as GV Medical, Inc., ATS Medical, Inc. and CABG Medical, Inc. Every year 250,000 Americans receive a life saving medical device developed by Manny.
Kips Bay Medical, Inc. (KIPS)
3405 Annapolis Lane North, Suite 200
Minneapolis, MN 55447 USA