R3 Vascular Advances Magnitude, the Thinnest Bioresorbable Drug-Eluting Stent, into Pivotal IDE Trial for Below-the-Knee PAD

Nov 05, 2024 22:15 CST Updated 22:15

R3 Vascular

Vascular Stent Developer

R3 VascularAnnouncing itsDrug-Eluting Bioresorbable ScaffoldMagnitudeReceived FDA approval to conduct an IDE study. Following FDA approval,R3 VascularComing SoonMagnitudeThe pivotal clinical study ELITE-BTK.

PI Evaluation

"Given the advancements and advantages of this trial, it is a highly anticipated trial. The next-generation technology has the potential to transform the field of peripheral interventions. We look forward to evaluatingEstimate Magnitude for Patient Treatment Outcome"The impact of the results and the ability to meet the growing clinical needs."

---Eric A. Secemsky Beth Israel Deaconess Medical Center

Executive Evaluation

"We are pleased to receive FDA approval for our ELITE-BTK pivotal trial, allowing us to begin enrollment for our next-generation bioresorbable scaffold."Magnitude Patients. This will enable R3 Vascular to follow up on our positive first-in-human RESOLV1 study data, which showed an outstanding and promising DUS patency rate of 96% at 6 months. The trial, set to begin in the first quarter of 2025, will be conducted across up to 60 global clinical sites with a total of 264 subjects. Upon reaching favorable conclusions, the company will be able to completeMagnitudeIn the FDA's PMA market application."

---Christopher M. Owens, President and CEO of R3 Vascular

Bioabsorbable stents are considered the future of treating infrapopliteal atherosclerotic disease. Abbott's Esprit BTK study, presented at the recently concluded TCT conference, showed that bioabsorbable stents not only outperform angioplasty in efficacy (with composite endpoints of limb salvage and primary patency nearly double those of angioplasty) but also demonstrate cost-effectiveness within one year post-surgery.

High effectiveness, safety, and cost-efficiency will make bioresorbable scaffolds highly welcomed by clinicians, patients, and medical insurance payers in the treatment of below-the-knee peripheral artery disease. Currently, the FDA has only approvedEsprit BTK LaunchMagnitudeIs very promising to become the second marketed bioresorbable scaffold and could potentially be Abbott's biggest competitor in this field.

R3 VasularCompleted an $87 million financing in May, which will advance rapidly and smoothly.ELITE-BTK Key Clinical Studies Conducted.

Magnitude

MagnitudeIs an ultra-thinDrug-eluting bioresorbable scaffold, itsThe strut is only 98μm.Esprit BTK is thinner.

MagnitudePrepared from a unique ultra-high molecular weight polylactic acid.Ultra-high molecular weight polylactic acid, combined with a unique stent design and pricing technology, enablesMagnitude BecomesMoreThinner, stronger, more flexible.

MagnitudeThe degradation time is predictable, due to the incorporation ofUltra-high Molecular Weight Polylactic Acid PolymerThe Ratio of Amorphous Regions to Crystalline Regions。Not only makesThe stent exhibits excellent strength, ductility, toughness, and resistance to fracture. Moreover, it ensures predictable stent degradation.

Magnitude Advantages

Excellent stent flexibility resists fracture and significantly adapts to changes in vessel diameter.
High Radial Strength and Circumferential Support
Balance of Strength and Ductility
Ultra-thin Design
The polymer exhibits significant structural stability during the degradation process.

R3 Vascular

R3 VascularR3 Vascular, Inc. is an innovative medical device company dedicated to developing best-in-class bioresorbable scaffolds that can rival metal drug-eluting stents. Its unique polymers and proprietary technology are used to create scaffolds that balance strength and flexibility for the treatment of peripheral artery disease (PAD).)。MagnitudeThe strut thickness of 98 microns across all available diameters is the thinnest absorbable stent tested in this clinical setting.