The FDA grants pre-market approval for CryoLife's Sologrip laser fiber optic delivery handset, used during surgery for inoperable heart conditions.
Vascular surgical device maker CryoLife announced a regulatory green light today with the FDA's pre-market approval of its Sologrip laser fiber optic delivery system.
Sologrip is a disposable handset designed to be used during surgery to support a relatively new procedure called transmyocardial revascularization approved by the FDA to treat difficult heart conditions.
CryoLife subsidiary Cardiogenesis Corp. specializes in the treatment system, indicated for patients with persistent angina and inoperable heart disease.
Atlanta, Ga.-based CryoLife specializes in implantable human tissue technologies to support cardiac and vascular surgery.
"We are pleased to receive FDA approval for our updated Sologrip handset. 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," said CEO Steven Anderson in a statement.
The company recently won European regulatory approval for its HeRo graft system, on the heels of FDA clearance for HeRo's next generation adapter.
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