Kaneka releasing a high-pressure balloon catheter to enlarge peripheral vessels

Kaneka Corporation
December 22,2017

Kaneka Corporation (Minato, Tokyo, Japan; President: Mamoru Kadokuka) started to sell a PTA *1balloon catheter (product name: SHIDEN HP) in November that can enlarge a blood vessel at high pressure for calcified lesions due to progressed peripheral arterial disease (PAD)*2.

Kaneka released a catheter usable with the guide wire with the minimum diameter of 0.014 inches which is used for treatment of PAD. The catheter is made resistant to 30*3 atmospheric pressure, which is the world’s highest level, enhanced from the conventional resistance of 22 atmospheric pressure*4 using Kaneka’s precision mold technology acquired over the years. It can satisfy a wide range of clinical needs such as clinical cases where blood vessels could not be enlarged enough for drug-coated balloon treatment and all sorts of stent placement using the conventional balloon catheter with limited pressure resistance.

In Japan, it is assumed that the number of patients suffering from PAD reaches 7 million. It is also said that those who must undergo leg amputation due to severe leg lesions come up to 10 thousand*5. Patients who conventionally could not avoid amputation of femoral or crural regions due to insufficient recovery of blood stream may be able to walk again after treatment using the product.

To provide resolution to various difficulties in blood vessel treatment, we will further enhance our product lineup and contribute to improvement in patient QOL.

  1. PTA: Percutaneous Transluminal Angioplasty
  2. Disease caused by poor circulation due to narrowed or blocked crural vessels and resulting in cold, numbness, dysbasia, pain, and ulcers and necrosis in severe cases.
  3. 30 atmospheric pressure is for a balloon diameter of 2 to 3 mm, 28 for 4mm, 24 for 5 mm and 20 for 6 mm.
  4. This pressure-resistance is proved in studies where 0.014-inch guide wire with a balloon diameter of from 1.5 to 4 mm is used (by Kaneka)
  5. Reported by Japan Society for Foot Care and Japanese Society of Limb Salvage & podiatric Medicine
 

Product photo of SHIDEN HP
balloon