Boston Scientific Corporation has acquired TriVascular, Inc., a privately held company based in Santa Rosa, California. Boston Scientific exercised an exclusive option to acquire TriVascular that it obtained in December 2002.
TriVascular was founded in 1998 to develop less-invasive medical devices and procedures for treating abdominal aortic aneurysms (AAA). This life-threatening condition creates a weakening and bulging of the aorta - the body's main blood carrying vessel. Conventional treatment involves invasive surgery requiring a large abdominal incision to implant a fabric graft to replace the damaged aorta. More recently, physicians have been able to use catheters to deliver devices that combine graft material with metal stents inside the aneurysm. This allows blood to flow through the "stent-graft" and bypass the aneurysm.
TriVascular's innovative AAA stent-graft design reduces the size of the TriVascular device by replacing much of the metal stent assembly with a polymer that is injected into channels within the stent-graft during the procedure. The resulting device can be delivered into the patient through a narrower delivery system. These characteristics are intended to provide a treatment option for a broad range of patients, including those patients with unusual anatomies such as those who harbour narrow blood vessels and atypical sized aortic necks. These types of patients typically are not candidates for currently available stent-grafts.
TriVascular successfully completed its first human implant of its AAA stent-graft in 2002 and clinical experience to date on 78 patients has shown promising results in Phase I studies. The US Phase II pivotal trial is planned to begin this year, and commercialization within the US is expected in 2008. CE mark is also expected this year. In addition, TriVascular is in the early stages of developing a thoracic aortic stent-graft, built on the same platform as the AAA stent-graft.
"TriVascular has made tremendous progress in the development of a durable stent-graft that we believe will offer a new solution for both our surgical and interventional customers," Paul LaViolette, Boston Scientific COO said adding, "The TriVascular AAA device reflects our commitment to bring more innovative products and add markets to our growing portfolio of cardiovascular solutions."
The market for AAA stent-grafts was approximately $370 million in 2004. However, market evolution and penetration has been limited. Of the 1.7 million patients in the US estimated to have aortic aneurysmal disease, only 360,000 patients (21 per cent) are diagnosed and just 60,000 (3.5 per cent) receive some form of treatment.