CryoLife receives premarket approval for Sologrip device

CryoLife has expressed confidence in the future success of its new Sologrip delivery system after it achieved a significant regulatory milestone.

The US Food and Drug Administration has granted premarket approval to the minimally invasive laser fiber-optic delivery system, which is designed for use with the Cardiogenesis transmyocardial revascularisation (TMR) device. 

A single-use disposable handset, Sologrip will facilitate the treatment of patients who are receiving TMR therapy for angina that has proven unresponsive to standard medications.

Studies have shown that TMR treatment with Cardiogenesis products can deliver angina improvements, longer event-free survival, reductions in cardiac-related hospitalisations and increased exercise tolerance.

Steven Anderson, chairman, president and chief executive officer of CryoLife, said: "We believe it will be well received by our customers and we look forward to continuing our efforts to increase adoption of this important treatment option for patients with angina."

This comes after the firm received European CE Mark approval for its HeRo Graft system last month.