Mechanical thrombectomy system receives FDA clearance
Philips announced that a mechanical thrombectomy system to remove blood clots from vessels within the peripheral arterial and venous systems has received 510(k) clearance from the FDA and is now available in the U.S.
The single-use system (QuickClear) incorporates both an aspiration pump and catheter and can simplify the thrombectomy procedure workflow, according to a press release from the company. The sterile device can be placed on the table next to the patient, and the system turns on within seconds with maximum aspiration power. Consistent aspiration power during the procedure gives physicians more control and may lead to faster procedure times, according to the release.
“QuickClear is a simple and easy to use mechanical thrombectomy system,” Bryan Fisher, MD, chief of vascular surgery at Tristar Centennial Medical Center in Nashville, Tennessee, said in the release. “The system is significantly smaller than other systems without compromising aspiration power. The convenience of the device really shines through with its single use and lack of capital equipment.”
The range of catheters for the system includes a 10F aspiration catheter, with can provide 59% more aspiration volume compared with 8F aspiration catheters, according to the release.
“Its intuitive design simplifies the entire thrombectomy procedure workflow,” Chris Landon, senior vice president and general manager of image-guided therapy devices at Philips, said in the release. “By taking away the high initial capital expenditure costs associated with traditional mechanical thrombectomy systems, QuickClear can help bring cost-effective solutions to both the hospital and outpatient care settings.”
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