Boston Scientific Korea said it has launched Wolverine Cutting Balloon Dilatation Device, a catheter for use in percutaneous coronary intervention (PCI).
PCI is a minimally invasive treatment that uses balloon catheters or stents to widen narrowed coronary arteries to improve blood flow to the heart.
Cutting balloon catheters are used for lesions that are difficult to treat with plain old balloon angioplasty (POBA) due to plaque buildup in the vessel, for in-stent restenosis (ISR), where the vessel narrows again after stenting, and for calcified lesions due to calcium buildup in the vessel.
Wolverine combines a balloon catheter with a microsurgical cutting blade, which is designed to create and hold an incision thinner than two strands of hair at the targeted location for safer and more precise atherectomy procedures.
It can also apply up to three times the force of a regular balloon catheter, effectively cracking calcium at low pressure with minimal damage to blood vessels and tissues.
Boston Scientific provides them it is available in a variety of sizes and with up to four micro-incision blades to customize treatment options for patients.
Despite the approval, under Korea's reimbursement standards, Wolverine can only be reimbursed when treating in-stent restenosis.
"As cardiovascular diseases such as myocardial infarction and angina pectoris are on the rise, we are excited that a cutting balloon dilatation that effectively fissures the plaque of calcified lesions that cause them has become available," said Professor Park Heon-sik of the Department of Cardiology at Kyungpook National University Hospital. "Although health insurance coverage is currently limited to only in-stent restenosis, I hope that the proven safety and efficacy of Wolverine will allow us to provide an optimized procedure for more patients in clinical settings."
Boston Scientific Korea's interventional cardiology business unit head Choi Il-woong also said, "Wolverine is a new product with an improved balloon body and catheter thickness compared to Flextome, which has been used in coronary interventions around the world for more than 25 years."
The company will continue to strive to provide Korean physicians with more treatment options for coronary interventions, Choi added.