Aspiration system for PE receives expanded indication
Penumbra announced its aspiration system to treat pulmonary embolism has received clearance for an expanded indication from the FDA.
The system (Indigo CAT 12 aspiration catheter with lightning intelligent aspiration [Lightning 12] and Separator 12), already indicated to treat PE, is now indicated to treat fresh, soft emboli from vessels of the peripheral arterial and venous systems, according to a press release from the company.
The treatment may reduce the need for thrombolytics use and ICU stays, the company stated in the release.
“Penumbra continues to strive to bring innovative therapies to the medical community, and this is another important milestone that will help advance pulmonary embolism intervention,” Adam Elsesser, president and CEO of Penumbra, said in the release. “COVID-19 has increased the awareness of the need for therapies that remove blood clots, and we are thrilled with the FDA clearance of the PE treatment indication for Lightning 12.”