VentiV Scientific has announced the US Food and Drug Administration (FDA) clearance of VentiV mechanical thrombectomy system to remove blood clots from the peripheral vasculature including the new VentiV Pulse platform.
“Electric pump-based thrombectomy systems can unexpectedly clog and/or remove 5–15ml per second of blood before removing blood clots,” said Dan Ryan, board of directors, VentiV Scientific. “The Pulse is designed to instantly start, stop, increase, and/or decrease thrombectomy force at the tip, decrease clogging inside the catheter, and decrease blood-loss with use of any aspiration pump currently in the hospital.”
“Patients, physicians, nurses, and technologists need more tools to treat diverse patient needs,” continued Ryan. “This FDA clearance includes 18Fr large-lumen catheter systems designed to solve unmet clinical needs and reduce procedural costs.”
The VentiV Scientific product line includes FDA-cleared over-the-wire catheters indicated for use in the peripheral vasculature plus rapid-exchange catheter systems cleared for use in the peripheral and coronary vasculature. VentiV’s unibody multi-strut thrombectomy basket retriever technology is under development and not FDA cleared at this time.
