Cardiovascular Systems and OrbusNeich this week announced that the OrbusNeich Scoreflex NC scoring percutaneous transluminal coronary angioplasty (PTCA) catheter has received FDA premarket approval. Scoreflex NC is a force PTCA scoring balloon with a dual-wire system that creates a focal stress pattern for safe and controlled plaque modification … [Read more...] about FDA grants PMA for Cardiovascular Systems, OrbusNeich Scoreflex scoring balloon