The data validate the safety and efficacy of the investigational device, with a high clinical success rate and 12-month data indicating freedom from reintervention in the majority of patients treated.

Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent results and a high rate of limb salvage in patients with CLI. Study outcomes through 1 year support the use of cryoplasty as a primary treatment option for patients with CLI secondary to BTK occlusive disease.

Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent acute outcomes and a high rate of limb salvage in patients with CLI. Study outcomes support the use of cryoplasty therapy as a primary treatment option for patients with CLI secondary to below- knee disease.