Neovasc Reports on Tiara Clinical Investigation Program
September 12, 2017—Neovasc Inc. announced an update on the study of the company's Tiara valve, a self-expanding mitral bioprosthesis for transcatheter implantation in patients with mitral regurgitation (MR).
According to the company, implantations of Tiara are being performed under three parallel clinical/investigational programs: TIARA-II, a European pivotal CE Mark trial; TIARA-I, a US Food and Drug Administration Early Feasibility trial; and compassionate use/special access treatment procedures.
Neovasc has received regulatory approval to conduct the TIARA-II study at a total of 10 centers; five in Italy, three in Germany, and two in the United Kingdom. The TIARA-II study, which is the primary focus of the Tiara program, is a 115-patient, nonrandomized, prospective clinical study evaluating Tiara's safety and performance. It is expected that data from this study will be used to apply for CE Mark approval in Europe.
In addition, Neovasc announced that it has recruited two new centers in the United States to participate in its TIARA-I study, and is actively recruiting in four centers in the United States, one center in Belgium, and three centers in Canada. TIARA-I is an international, multicenter early feasibility study being conducted to assess the safety and performance of the Tiara mitral valve system and implantation procedure in high-risk surgical patients with severe mitral regurgitation.
The company advised that 34 patients have been treated with the Tiara valve at 10 medical centers in the United States, Canada, Germany, Italy, Belgium, Switzerland, and Israel. The technical success rate in these implantations is 31/34, or 91.1%.
In the technically successful implantations, paravalvular leak levels were reported as mild, trace, or absent in 100% of these cases. All-cause, 30-day mortality in the 33 patients who have reached 30-day follow-up after implantation with Tiara is 12.1% (4/33). The remaining patient treated within the last 30 days is recovering well. To date, the longest surviving patient has passed 3.5-year follow-up after implantation.
Professor Ulrich Schafer, MD, an interventional cardiologist at the University Heart Center Hamburg, Germany is one of the Principal Investigators in the CE Mark trial for the device. In the company's press release, Prof. Schafer commented, "Transcatheter implantation of the Tiara mitral valve resulted in immediate elimination of MR and improved the performance of the heart, without the need for any cardiac support device and with no procedural complications. The results we see so far are very encouraging in this very sick and high-risk patient population. These patients with severe MR and severe heart failure tolerate the Tiara implantation procedure without any major issues, and most of them are discharged to home 3 to 5 days after the valve implantation."
Anson Cheung, MD, a Principal Investigator of the TIARA-I study, will present an update on the Neovasc Tiara program at PCR London Valves 2017 conference to be held September 24–26 in London, United Kingdom. On September 9 in San Francisco, California, Paulo Denti, MD, Principal Investigator at San Raffaele Hospital in Milan, Italy, presented a Tiara case at CSI-UCSF 2017, a conference hosted by the CSI Foundation in association with the University of California, San Francisco, noted the company.