Medical device firm V-Wave has recruited first patients in its pivotal study to assess the safety and efficacy of its heart failure therapy.
Image: V-Wave has enrolled first patients in novel heart failure therapy study. Photo: courtesy of ddpavumba / FreeDigitalPhotos.net.
V-Wave has begun the 500-patient patient study to evaluate the safety and efficacy of minimally invasive implanted interatrial shunt device to treat patients with NHYA Class III and ambulatory Class IV symptomatic heart failure (HF).
The Relieve-HF trial, which is funded by the firm’s $70m early 2018 C-Round financing, will assess the device therapy in severe HF patients with either preserved or reduced ejection fraction.
The first two patients in the study have been successfully implanted and discharged from the Ohio State University Wexner Medical Center.
Garrie Haas is the principal investigator of the study, while Scott Lilly and Rami Kahwash ae taking responsibility for implantation and patient management.
The trial will recruit patients at around 50 major North American hospitals, and will also use another 25 centers in the EU and Israel.
The study protocol enables to include a range of patients who are expected to have the best chance of benefitting from the treatment.
According to the company, the primary effectiveness outcome measure includes a hierarchical composite of mortality, heart transplant or ventricular assist device implantation, HF hospitalizations, and change in six-minute walk test distance.
The interatrial shunt system is currently under investigation, and is not yet approved for sale in the US or other countries.
V-Wave CEO Neal Eigler said: “The interatrial shunt provides a novel therapeutic approach for patients with chronic HF. The shunt is implanted through a catheter inserted in a vein in the leg.
“Prior clinical experience demonstrated device and implantation procedure safety, and statistically significant improvements in symptoms, quality of life measurements, and exercise capacity were observed compared to a matched population receiving optimal care.”
V-Wave’s $70m Series C financing was led by Deerfield Management along with participation from new investors – healthcare funds Endeavour Vision, Quark Venture and Aperture Venture Partners.
All of V-Wave’s existing major investors are also participated in this round, including investors Johnson & Johnson Innovation, Edwards Lifesciences, and others.