R3 Vascular today announced that it has received WCG Institutional Review Board (IRB) approval for the ELITE-BTK pivotal trial of its Magnitude drug-eluting next-generation bioresorbable scaffold for below-the-knee (BTK) peripheral arterial disease (PAD). This approval allows the trial to take place at institutions that utilise WCG IRB as their central IRB in the USA. Additionally, the company has announced that the Centers for Medicare and Medicaid Services (CMS) has granted category B approval for the investigational device exemption (IDE) study, ensuring Medicare coverage for the device, related and routine items, and services for the ELITE-BTK trial.
Commenting on the announcements, Christopher M Owens, president and chief executive officer of R3 Vascular, said: “We are very pleased to have received IRB and CMS category B approval so quickly. These important milestones validate the potential of R3 Vascular’s breakthrough technology and help accelerate our path to first enrolment of our ELITE-BTK pivotal trial to measure the impact of Magnitude on patient outcomes and its ability to meet this critical and growing clinical need.”
Josh Smale, vice president of global clinical and scientific affairs of R3 Vascular, added: “Securing WCG and CMS approvals enables us to move forward quickly with investigational site activation activities, which brings us one step closer to first subject enrolment. I’m extremely proud of the great work our team has done to continue to accelerate and maintain our momentum between these milestones, as well as our continued urgency to get this next-generation product delivered to patients.”
Eric A Secemsky (Beth Israel Deaconess Medical Center, Boston, USA), lead investigator for the ELITE-BTK pivotal trial, said: “R3 Vascular’s novel approach in the design of its next-generation bioresorbable drug-eluting scaffold is of great interest to the physician community and has the potential to transform the field of peripheral interventions. We are eager to assess the impact of the Magnitude scaffold on patient outcomes, which is now even closer to reality with the completion of these latest important milestones.”
In May of 2024, R3 Vascular announced the closing of its US$87 million Series B financing round to support the ELITE-BTK IDE pivotal trial as well as additional research and development, global regulatory submissions, scale up of manufacturing processes, and initial commercialisation.
