First patients successfully treated with ByCross atherectomy system
12 October 2018 – Taryag Medical, the R & D Partner-Company of plus medica, announced today that six patients have been successfully treated with the Company’s ByCross Atherectomy System in a first-in-man (FIM) trial. The cases were performed by Dr. Joerg Tessarek at Bonifatius Hospital in Lingen, Germany, as well as by Prof. Dr. Ralf Kolvenbach at Augusta-Krankenhaus in Dusseldorf, Germany.
The ByCross FIM trial will enroll 42 patients by the end of January 2019. Follow-ups will continue to the middle of next year. “We have used the device in very challenging cases, with excellent results—so far”, Prof. Dr. Kolvenbach says.
ByCross is a single-use, fully disposable rotational atherectomy device with an expandable atraumatic tip, which allows the device to efficiently treat arteries in a range of sizes. The system also includes a non-clogging aspiration system, and is designed to restore blood flow in many types of lesion morphologies encountered with peripheral vascular disease. ByCross consists of a motor driven shaft that accepts a standard 0.035″ guide wire and is accommodated inside a 6F sheath. The shaft rotates at ~6000 RPM with an expandable distal tip (1.7–4.7mm) that effectively drills into and breaks down atheroma into small particles, which are simultaneously sucked into a collection bag through the 6F sheath.
Describing the benefits of using the ByCross atherectomy system, Prof. Dr. Kolvenbach says: “Normally, when you have a long occlusion of, for instance, the superficial femoral artery, there is a lot of calcium present. A continual suction technology is part of the ByCross device, which sucks out all of the debris created by drilling into calcium—so the risk of the procedure as such should be significantly reduced compared to other devices.”
Furthermore, the flexibility of the ByCross atherectomy device facilitates delivery in tortuous anatomies. The device is available in various lengths (50–135cm) for distal anatomy and contra lateral access. The device consists of electronic components that control the rotation speed, torque, and indications for use in malfunction.
The ByCross device is introduced into the blood vessel and crosses the occlusion while the tip is closed, or collapsed. The physician can then advance the guide wire through the occlusion, and expand the tip. ByCross allows constant injection of contrast material to the distal tip, to improve the safety and the control of the procedure. In addition, a remote control unit which can be mounted onto the introducer sheath allows the physician to operate the device without losing visual and physical contact throughout the procedure. While holding the introducer sheath, the physician can operate the device via the remote control unit using one hand, and simultaneously advance the device into the vessel with the other hand.