Terumo has announced receiving the CE mark for its Kanshas drug-coated balloon catheter used in the treatment of lower extremity peripheral arterial disease.
With a September launch planned in Europe, Terumo is expected to be the first Japanese company to launch drug-coated balloon sales in Europe, and the European launch will be followed with launches in Latin America and Asia, as well.
A drug-coated balloon catheter is a medical device coated with a drug that suppresses cell proliferation on the balloon surface. When the balloon is expanded, it comes into contact with the blood vessel walls, transferring the drug to the vascular tissues, which is expected to suppress restenosis.
Early data on head-to-head comparisons of drug-coated balloons are beginning to emerge.
Kanshas can be expected to have an enhanced therapeutic effect due to Terumo’s proprietary uniform micro-crystal coating named Unicoat, which has been designed so that the coated drug is less likely to migrate before it reaches the lesion and then transfers swiftly to vascular tissue when the balloon is expanded. Product line-up of long balloon with a range up to 200mm can be treated for long lesions, which are common in the lower extremities.
Terumo is aiming to expand its peripheral vascular intervention business globally and is building up its product portfolio, a company release states. The launch of Kanshas is part of this strategy. Going forward, Terumo is determined to enhance its contribution to medical treatment in the endovascular field, the release adds.