Perfuze receives FDA Clearance for stroke treatment catheter

Perfuze has received FDA 510(k) clearance for its Millipede88 Aspiration Catheter, marking the company's entry into the super-bore aspiration segment of the mechanical thrombectomy market.

The clearance follows completion of the MARRS clinical study, which met all primary objectives. The device is the first standalone 0.088-inch catheter cleared for direct aspiration, allowing physicians to achieve reperfusion without additional devices.

The Millipede88 features a patented corrugated design intended to navigate tortuous blood vessels while maintaining aspiration force. In the MARRS trial, the catheter achieved a 96% deliverability rate and 77% first-pass effect in M1 occlusions, according to Raul Nogueira, the study's principal investigator and division chief of cerebrovascular medicine at UPMC.

"In stroke—where every minute of delay costs brain tissue—technology that improves the likelihood of achieving reperfusion on the first pass represents a meaningful advance," Nogueira said.

The device aims to reduce procedural complexity and per-case costs while potentially saving time for stroke patients, the company said.

Perfuze CEO Wayne Allen called the clearance "a defining moment" for the company and stroke intervention. The corrugated design distinguishes the Millipede88 from conventional super-bore catheters, which can lose lumen integrity in curved anatomy, he said.

The company will begin a limited market release at select U.S. comprehensive stroke centers, with broader commercialization planned. The device complements Perfuze's recently cleared Zipline Access Catheter family.

Super-bore aspiration represents the fastest-growing segment of the mechanical thrombectomy market as stroke centers increasingly adopt aspiration-first strategies, according to the company.

Advances in stroke intervention

Mechanical thrombectomy has transformed acute ischemic stroke treatment over the past decade, with clinical evidence demonstrating superior outcomes compared to medication alone for large vessel occlusions. The procedure, which involves threading catheters through blood vessels to physically remove clots blocking blood flow to the brain, has become standard of care at comprehensive stroke centers.

Recent developments have focused on improving first-pass reperfusion rates—the ability to restore blood flow in a single attempt. Higher first-pass success correlates with better patient outcomes and reduced procedure times, critical factors given that stroke patients lose approximately 1.9 million neurons per minute during vessel occlusion.

The evolution toward larger-bore aspiration catheters reflects the field's shift from stent retriever-first approaches to direct aspiration techniques. Super-bore catheters, typically 0.088 inches in inner diameter, offer greater suction capability for removing clots while potentially reducing the need for multiple devices during procedures.

Engineering challenges remain in balancing catheter size with deliverability through the brain's complex vascular anatomy. Tortuous vessels, particularly common in elderly patients, can cause larger catheters to collapse or deform, reducing their effectiveness. Innovations in catheter design, materials and structural architecture aim to maintain device performance across diverse patient anatomies.

The mechanical thrombectomy market has grown substantially as evidence supporting the technique has accumulated and as eligibility criteria have expanded to include patients previously considered unsuitable for intervention. Treatment windows have extended based on advanced imaging that identifies viable brain tissue, allowing more patients to benefit from mechanical clot removal even hours after symptom onset.