The US Food and Drug Administration (FDA) has cleared Covidien's SpiderFX device, indicated for use in arteries in the lower extremities to treat severely calcified lesions.
The move follows the results from the Definitive Ca++ clinical study, which showed that SpiderFX, along with Covidien's TurboHawk device, safely and effectively treated patients who have severely calcified superficial femoral artery and popliteal artery lesions.
Cleveland Clinic Department of Vascular Surgery chairman Daniel Clair said that in complex situations, the SpiderFX device shows promise of being a positive step forward for treating patients with peripheral arterial disease.
"The expanded indication of these devices offers interventionalists a safer option for dealing with severely calcified lesions,'' Clair said.
Covidien Vascular Therapies chief medical officer Mark Turco said that his company's aim is to educate clinicians about the importance of using an embolic protection device during high-risk situations.