FDA clears Spectranetics' atherectomy device for infrainguinal arteries
The FDA has approved Spectranetics' Turbo-Tandem, a single-use, disposable device indicated for atherectomy of infrainguinal arteries. CE mark approval was received earlier this month.
The Turbo-Tandem System is comprised of two devices, a 7 French laser guide catheter in combination with a 2 mm excimer laser ablation catheter, according to the Colorado Springs, Colo.-based company. The Turbo-Tandem is designed to perform atherectomy and ablation of plaque in arterial lesions above the knee, primarily within the superficial femoral and popliteal arteries.
The Turbo-Tandem System is comprised of two devices, a 7 French laser guide catheter in combination with a 2 mm excimer laser ablation catheter, according to the Colorado Springs, Colo.-based company. The Turbo-Tandem is designed to perform atherectomy and ablation of plaque in arterial lesions above the knee, primarily within the superficial femoral and popliteal arteries.