BioVentrix has received renewal of the highest priority reimbursement in Germany for its Revivent TC transcatheter ventricular enhancement system.
A company statement announced that it has been given NUB Status 1 designation from InEk, the German Institute for Hospital Remuneration. The NUB process enables participating German hospitals to receive full reimbursement plus a supplemental payment when using groundbreaking medical technologies not listed in the existing German healthcare system. According to the press release, NUB Status 1 was only assigned to a handful of innovative technologies. This is the fourth consecutive year that the Revivent TC System has achieved this status in >100 hospitals in Germany.
Kenneth Miller, president and chief executive officer of BioVentrix, states in the press release: “Achieving the highest possible reimbursement level in Germany again this year demonstrates that the German healthcare system recognises the impact that the Revivent TC System is having on heart failure patients with few options. We are gratified to not only be able to improve the hearts of patients who need help, but to also do it in a way that improves the economics of treating heart failure.”
The statement also points out that Less Invasive Ventricular Enhancement, or the LIVE Therapy, uses the Revivent TC System to exclude scar tissue on the left ventricle that has occurred from a heart attack so the healthy portion of the heart can operate more efficiently. Microanchors are implanted and designed to remodel the heart to a more normal shape and size and reduce wall stress, which has been shown to improve blood flow throughout the body.
The company says it is currently enrolling patients in the REVIVE-HF postmarket study in Europe, a randomised, controlled, prospective, multicenter, dual-arm study evaluating the Revivent TC System against guideline-directed medical therapy. The study is expected to enrol 180 patients. In the USA, the company is currently enrolling patients in a pivotal trial of the Revivent TC System, the ALIVE Trial.
The Revivent TC System has received the CE mark and is approved for sale in Europe. It is considered investigational and is not approved for sale in the USA.