Boston Scientific and TriVascular, Inc. Announce Strategic Alliance
Boston Scientific secures access to percutaneous aortic aneurysm stent graft
NATICK, Mass., Jan 14, 2003 (PRNewswire-FirstCall) - Boston Scientific Corporation (NYSE: BSX) today announced that it has entered into a series of agreements with TriVascular, Inc., including an investment in the company, exclusive international distribution rights, and an exclusive option to acquire the company. TriVascular is a privately held company located in Santa Rosa, CA that was founded five years ago with the objective of improving the outcome from abdominal aortic aneurysm (AAA) therapy by developing a more durable stent graft that could be placed percutaneously (through the skin).
TriVascular's first commercially available product is designed to have a delivery catheter that is small enough (approximately 12 French) to allow the physician to make a small puncture in the leg instead of an incision. TriVascular reduced the delivery system size by eliminating much of the metal required to keep other stent grafts open and replacing it with a polymer that is injected into channels within the graft during the procedure.
The company successfully completed its first human implant in August and recently received an approval from the U. S. Food and Drug Administration to begin its U. S. clinical trial. TriVascular anticipates receiving a CE mark in late 2003. Multiple additional applications of the technology are in development. Terms of the agreements were not disclosed.
An abdominal aortic aneurysm is a weakening of the wall of the largest artery in the body. If left untreated, it can expand and rupture, resulting in a mortality rate in excess of 50 percent. It has been estimated that one of every 250 people over the age of 50 will die of a ruptured AAA, making this one of the leading causes of death in the U. S. Traditional surgical repair of an AAA is an invasive and traumatic procedure that requires a large incision in the abdomen, which allows a physician to place a graft inside the aorta. A less-invasive approach was developed in the early 1990's that combined a fabric graft with a metal stent structure that held the graft in place. These stent grafts eliminated the need for an open abdominal procedure. Instead, the new grafts are delivered via a catheter (approximately 20 French in size) through an incision in the patient's leg.
"Boston Scientific has long sought a durable stent graft that offers a percutaneous solution for both our surgical and interventional customers," said Paul LaViolette, Boston Scientific Senior Vice President and President, Cardiovascular. "We believe that TriVascular is the first to have developed a solution that substantially decreases the profile of the device down to a percutaneous range while also enhancing the durability of the graft."
"I'm excited by how our team has risen to the challenge of creating a unique, durable and yet percutaneous solution to the minimally invasive treatment of aneurysms," said Michael Chobotov, Ph.D., President and Chief Executive Officer of TriVascular. "Through hard work, creativity, and the application of advanced technologies and methods, we believe we have developed a true next generation solution to this significant unmet clinical need."
The market for AAA stent grafts was approximately $250 million in 2002. However, market evolution and growth has been limited. Many believe the market could triple if a device was developed that could be placed percutaneously and was durable enough to reduce the need for re-intervention.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices. Its products are used in a broad range of interventional medical specialties.
This press release contains forward-looking statements. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in its filings with the Securities and Exchange Commission.