endovascular.es

Título: FDA 510(k) Clearance and Initial US Clinical Use of the Wingman35 Crossing Catheter
Fecha: 23-10-2014
ReFlow Medical, Inc. (ReFlow) today announced FDA clearance for US commercialization of their Wingman35 Crossing Catheter for use in the peripheral vasculature as well as the first US clinical cases with the device. The initial US cases were performed by Dr. John R. Laird at the UC Davis Vascular Center in Davis, California, and Dr. Mahmood Razavi at St. Joseph Heart & Vascular Center in Orange, California. The Wingman35 Crossing Catheter is indicated to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature and enable rapid, routine, off-the-shelf lesion crossing.

“My first clinical cases with the Wingman35 were impressive and consistent with my prior experience with the Wingman14,” says Dr. Laird. “The device tracked easily through tortuous anatomy and over my workhorse .035 guidewire. The device brings the functionality of a support catheter with the added benefit of knowing I can cross tough lesions by extending the bevel tip if need be. I’m very excited with the added capabilities that these crossing catheters bring to my lab while still being cost-effective and saving me considerable time during the procedure.”

Dr. Mahmood Razavi stated, “My initial experience with the Wingman35 went very well. It offered me great support and compatibility with my wires while allowing me to cross a previously attempted ISR that was unsuccessful. The time savings on that case, in particular, gave me the opportunity to treat more patients that day.”

ReFlow Medical President and CEO, Isa Rizk, commented, “The Wingman35 represents an important addition to the Wingman product line, soon to be followed by additional portfolio products. We look forward to continuing to provide the physicians with a full toolbox that helps them more easily address their daily clinical needs.”
About ReFlow Medical, Inc.
ReFlow Medical, Inc. is a private company focused on empowering physicians through the design and development of innovative and cost-effective technologies for cardiovascular disease.
Contacts
ReFlow Medical, Inc.
Leslie Hamer, 949-481-0399
Fuente: endovascular.es

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