Penumbra launches Ace68 Reperfusion thrombectomy catheter

Penumbra today announced the U.S. launch of the Ace68 Reperfusion thrombectomy catheter designed for extracting thrombus in acute ischemic stroke patients.

The company said the Ace68 catheter was engineered on an entirely new platform from hub to tip, which features coil winding geometry along 16 transitions to create a more optimal tracking profile.

“With the Ace68 Reperfusion Catheter, I can easily deliver full aspiration power to the occlusion. The Ace68’s large lumen increases the likelihood of capturing the clot fully within the catheter or the canister, potentially reducing the number of passes to achieve complete revascularization and minimize ENT,” Dr. Johanna Fifi of New York’s Mount Sinai Health System said in a press release.

“The tracking technology of the Ace68 Reperfusion Catheter is the most advanced. In my clinical experience with the Ace68, I saw the device easily navigate difficult tortuosity that would have challenged other devices. Ace68’s tracking performance, combined with a large aspiration lumen to enable efficient clot removal, make Ace68 the most compelling frontline device in stroke intervention,” Dr. Blaise Baxter of Chattanooga’s University of Tennessee College of Medicine said in a prepared statement.

The Penumbra System with the Ace68 Reperfusion catheter is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset, the company said.

The Ace68 is designed to extract clot en mass as part of the fully integrated Penumbra system, the company said.

“We designed the Ace68 with the intent to make real improvement on stroke procedure time, outcome and cost. The early reports from physicians on the performance of Ace68 confirm that this is the most impactful stroke product we have ever developed,” CEO Adam Elsesser said in prepared remarks.

In April, Penumbra said it launched its Lantern peripheral microcatheter and reported Phase IV data from a 100-patient trial of its Indigo peripheral thrombectomy device.

The Lantern device won 510(k) clearance from the FDA in December 2015 for the peripheral and neurovascular delivery of diagnostic agents and therapeutic devices such as occlusion coils. Alameda, Calif.-based Penumbra makes the Ruby coil, Penumbra occlusion device and its packing coil.

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