Key Elements The unique Endovalve minimally invasive surgical mitral valve replacement system consists of a prosthetic heart valve that has a single-piece tripod-like structure with gripping features and a support ring for valve leaflets made of standard biologic material. The prosthetic valve is folded in into a 32Fr catheter for direct delivery into the left atrium.
The device is then unfolded at the point of deployment in the left atrium and then anchored into the existing native mitral annulus and leaflet tissue via its proprietary gripping features (thus enabling a fully valve sparing procedure). The prosthesis can be repositioned prior to locking it into its final anchored state.
Use of a folding structure allows a low profile for insertion via a catheter, and a large profile once deployed.
Benefit
Highlights
The ability to perform a mitral valve replacement via minimally invasive surgery would be a cost-effective alternative to open-heart surgery and presents a compelling opportunity to expand the eligible patient population. It is a logical extension of a cardiac surgeon’s skill set. Designed to be very simple and straightforward, the procedure should take about two to three hours to accomplish. Our hope is that patients should experience speedier recovery times and shorter hospital stays.
Patents Published and Pending
The foundational technology for our proprietary system was developed by a team at the University of Pennsylvania led by interventional cardiologist Dr. Howard Herrmann, who now chairs our Scientific Advisory Board, the members of which have world-class reputations and strong FDA relationships. The university’s Office of Technology Transfer filed for a nonprovisional patent in July 2004 for the unique design of the valve; this was followed by national phase filings in January 2006. The United States application published in January 2007, and international patents remain pending. Endovalve has a worldwide exclusive license to the technology; design work has led to additional intellectual property filings; and the company will continue to file patent applications as the development program advances.
Turning
Technology into Product
To maximize the use of early-stage capital, we have taken a cost-effective approach to accelerated product development. Under the supervision of Endovalve R&D Vice President Todd Tomba, an outsourced integrated project team of some 20 engineers are involved from prototype design and bench testing through pilot preclinical testing and final design recommendations.
The technology platform supporting the development of the mitral valve replacement system to be delivered through minimally invasive surgery also is intended to support later development of a percutaneous system, utilizing the same valve design.
