The MAGNITUDE drug-eluting bioresorbable scaffold is designed to treat below-the-knee peripheral arterial disease. Credit: mind_photo / Shutterstock.

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to commence the ELITE-BTK trial of MAGNITUDE, a drug-eluting bioresorbable scaffold.

The trial is anticipated to commence in Q1 2025 and will enrol 264 subjects at up to 60 clinical sites across the globe.

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Created using an ultra-high molecular weight polylactic acid polymer, this scaffold is intended to treat below-the-knee (BTK) peripheral arterial disease (PAD).

When combined with R3 Vascular’s scaffold design and processing technology, the polymer results in a “thinner, stronger, and more flexible” scaffold.

The scaffolds are designed to be absorbed gradually into the tissue without leaving any material behind.

MAGNITUDE will be analysed for its potential to treat patients with chronic limb-threatening ischemia caused by BTK PAD.

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R3 Vascular president and chief executive officer Christopher Owens 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. 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 at six months.

“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 market application for MAGNITUDE with the FDA.”

In preparation for the ELITE-BTK trial, R3 Vascular secured $87m in a Series B financing round in May 2024.

These funds will also be used for conducting further research and development, regulatory submissions worldwide, scaling up manufacturing processes, and commercialisation efforts.

R3 Vascular is developing fully bioresorbable, drug-eluting vascular scaffolds coated with sirolimus.

Designed to offer the structural support of a stent, these scaffolds also deliver the anti-inflammatory and anti-proliferative benefits of sirolimus, gradually dissolving as the vessel naturally heals.