US-based bioabsorbable scaffold company, R3 Vascular, has been granted investigational device exemption (IDE) approval by the US Food and Drug Administration (FDA) to launch its ELITE-BTK pivotal trial of its peripheral arterial disease (PAD) treatment.
The California company has said that the approval paves the way for trials set to begin in Q1 of 2025 examining the company’s bioresorbable scaffold, dubbed Magnitude, designed to treat chronic limb-threatening ischemia resulting from below-the-knee PAD. R3 claims that its bioresorbable scaffolds are made from a unique, ultra-high molecular weight polylactic acid polymer that allows it to be much more flexible whilst being able to maintain its strength at larger sizes.
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The announcement follows $87m in series B funding which was secured earlier in 2024, dedicated to launching the ELITE-BTK trials. The trials will be conducted at up to 60 global clinical sites including 264 patients with the company preparing to move toward market application for Magnitude.
Eric Secemsky, lead investigator for the ELITE-BTK pivotal trial, said: “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.”
Research conducted by the US National Institutes of Health (NIH) found that PAD affects approximately 8 to 12 million people across the country, mostly over the age of 50. GlobalData epidemiologists estimate there were 18,386,656 diagnosed prevalent cases of PAD globally in 2023, which are expected to grow to 18,751,586 cases by this year.
Christopher Owens, president and chief executive officer of R3 Vascular, said: “We are pleased to have FDA approval for our ELITE-BTK pivotal trial, thus allowing enrolment to begin for our next-generation MAGNITUDE scaffold.”
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By GlobalDataElsewhere in the market of PAD treatment, AngioDynamics has secured a European CE mark for the Auryon Atherectomy System, a laser technology used for the treatment of peripheral artery disease (PAD).
