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.
“Like many Penumbra products, the Lantern microcatheter is unique in its design and helps address physician needs for a low profile, high flow microcatheter,” chairman & CEO Adam Elsesser said in prepared remarks. “It is designed to track distally through the peripheral vasculature, yet can be used for high flow contrast injections, combining these desired properties into one microcatheter.”
Penumbra also said that the 83-patient Prism trial of its Indigo device met its safety and efficacy endpoints, showing serious adverse events in 10 patients (12.0%), none device-related. The efficacy endpoint, vessel patency, was achieved in 89.0% of patients treated with thrombectomy alone and 96.3% of patients treated with thrombectomy plus lytic therapy.
Serious adverse events were reported in 10 patients; none were device related. The results were released at the annual meeting this week of the Society for Interventional Radiology in Vancouver.
“The Penumbra/Indigo System proved safe and effective in restoration of flow to patients suffering from peripheral occlusions relating to events of acute ischemia, failed thrombolysis, and distal emboli as a complication of previous interventions. The PRISM study demonstrated thromo-aspiration to be safe and effective in revascularization of peripheral and visceral arterial occlusions. The final results of this trial supports the utility of this system across a wide range of applications in the peripheral vasculature,” the researchers found.