TriVascular Technologies raises $10m, launches study of EVAR in women

Trivascular Technologies (NSDQ:TRIV) said it raised a $10 million funding round and launched a clinical study of endovascular aortic repair in women using its Ovation stent graft. Santa Rosa, Calif.-based TriVascular said in a regulatory filing that it raised $10 million from 5 unnamed investors in a debt-and-warrants offering. The company, which won pre-market approval from the FDA this month for its Ovation iX device, raised $78 million in April 2014 with an initial public offering. TriVascular also said today that it launched the Lucy study, which aims to enroll up to 225 subjects (75 women in the treatment cohort and 150 men in the control group), to compare use of the Ovation system between the genders. Women are an underserved population in EVAR because of generally smaller access vessels and often-challenging aortic neck anatomies, TriVascular said. The study, a prospective, consecutively enrolling, non-randomized multi-center post-market registry, has a primary endpoint of major adverse events within 30 days, the company said. “We are excited to participate in this important study,” Dr. Krishna Mannava, who treated the 1st patient in the study at  Fairfield Medical Center in Lancaster, Ohio, said in prepared remarks. “The Ovation system is ideally suited for patients with small-diameter access vessels and diseased aortic necks, which is often characteristic of female patients. Our first Lucy case went well and we are excited to continue enr...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Endoscopic / Arthroscopic Stent Grafts Vascular TriVascular Source Type: news