R3 Vascular today announced that the US Food and Drug Administration (FDA) has granted the company investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of the next-generation Magnitude drug-eluting bioresorbable scaffold for below-the-knee (BTK) peripheral arterial disease (PAD).
“We are pleased to have FDA approval for our ELITE-BTK pivotal trial, thus allowing enrolment to begin for our next-generation Magnitude scaffold. This will enable R3 Vascular to follow-up on our positive first-in-human RESOLV1 study data, which demonstrated excellent and promising results with 96% patency by DUS [Duplex ultrasound scanning] at six months,” said Christopher M Owens, president and chief executive officer of R3 Vascular. “Initiation of this trial will begin in Q1 2025 and will be conducted at up to 60 global clinical sites with 264 subjects, and upon favourable conclusion will allow the company to complete and pursue a PMA [premarket approval] application for Magnitude with the FDA.”
R3 Vascular notes that Magnitude is a next-generation bioresorbable scaffold with the potential to address one of the greatest needs for patients suffering from chronic limb-threatening ischaemia (CLTI) due to below-the-knee PAD.
“R3 Vascular’s novel bioresorbable scaffolds are made from a unique, ultra-high molecular weight polylactic acid polymer. This polymer, combined with the company’s scaffold design and proprietary processing technology allow the sirolimus-coated scaffolds to be thinner, stronger, and more flexible even at larger diameters and longer lengths,” a company press release reads. “R3 Vascular scaffolds are specifically engineered to ensure that they gradually and predictably absorb into the tissue, leaving nothing behind and enabling a more naturally functioning vessel.”
Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA), lead investigator for the ELITE-BTK pivotal trial, said in the press release: “This is a much-anticipated trial given the advancements and advantages of this next-generation technology, which has the potential to transform the field of peripheral interventions. We look forward to evaluating the impact of Magnitude on patient outcomes and its ability to meet this growing clinical need.”
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.
