CVIT Issues Guidelines for Proper Use of the Jetstream Atherectomy System

According to the guidelines, physicians who can use the product must meet all three of the following requirements: "must be a CVIT-certified physician, a specialist of the Japanese Society for IVR, or an endovascular surgeon certified by the Japanese Society for Vascular Surgery," "must attend a training program on the product," and "must be used by a physician experienced in endovascular therapy for peripheral occlusive artery disease. The physician must meet all three of the following criteria.

The requirements are that the facility must be "a CVIT-accredited training facility or training-related facility, an IVR specialist training facility, or a training facility accredited by the Japanese Board of Cardiovascular Surgery," "have a system in which DSA equipment is permanently installed in the operating room or angiography room," and "have an emergency system for complications associated with atherectomy and balloon dilation in collaboration with the Department of Surgery.".

In addition, the following four points were noted.

1. In domestic clinical trials, this product should be used for the purpose of using DCBs in severely calcified lesions, as the standard use of this product was in combination with drug-coated balloons (DCBs).
2. The efficacy and safety of this product for lesions larger than 150 mm have not been evaluated in domestic clinical trials.
3. There may be an increased risk of distal embolization and other events when passing through non-severely calcified lesions.
4. The efficacy and safety of this product for "primary stenting" have not been evaluated.