The Scoreflex balloon catheter from OrbusNeich, a Hong Kong based interventional cardiology device company, has received the EU CE Mark of approval today. The Scoreflex catheter differentiates itself from other balloon catheters out there by utilizing what it calls focused force angioplasty. This allows interventional cardiologists to focus the force of the balloon in specific areas of the plaque for cracking into resistant areas, as well as minimizing trauma to the blood vessel wall.
CE Mark approval is given to a product that has been demonstrated to meet European minimum standards and safety specifications. This product is not currently available in the United States, and will probably be competing against Guidant’s popular FX miniRAIL focused force angioplasty balloon.
Read the press release here…