News | October 02, 2014

ReFlow Gains CE Mark, Initial Clinical Use of the Wingman35 Crossing Catheter and SpeX Shapeable Support Catheter

ReFlow CE Mark Wingman35 Crossing Catheter SpeX Shapeable Support Catheter

October 2, 2014 — ReFlow Medical Inc. announced the initial clinical use of its Wingman35 Crossing Catheter and speX Shapeable Support Catheter by Dr. Andrej Schmidt at University Leipzig, Germany. The devices were recently granted European Union CE mark approval for use in the peripheral vasculature. The new Wingman35 Crossing Catheter allows the physician to use their 0.035-inch guidewire of choice during procedures, and the new speX Shapeable Support Catheter provides physicians with a shapeable tip option to meet their specific case needs.

“Building on the Wingman14 design, the addition of the Wingman35 to the portfolio now expands the choice of wire I can use when treating my patients,” Schmidt said. “The unique extendable bevel tip gives me the ability to utilize the Wingman as a daily support catheter with the added benefit of crossing lesions when needed. The speX shapeable catheter further expands my capabilities with the Wingman14 device because it retains its shape and allows me to reshape as needed. I can rapidly adjust to the specific needs of each case and each patient, with predictable results.”

ReFlow Medical President and CEO, Isa Rizk, commented, “The addition of these new devices expands on our current 0.014-inch offering and builds a broad suite of products that give the physicians more options when treating a wide variety of lesions. We are thankful for the input from our scientific advisory board — we worked closely with them to develop these products. We look forward to continue to change the rules for vascular access by introducing additional products in the near term that meet the need for simple, yet effective solutions.”

ReFlow Medical has submitted applications to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of both devices, which are currently under review.

For more information, please visit

Related Content

Navitian Coronary Microcatheter Receives CE Mark Approval
News | Catheters | February 21, 2019
Navitian, the new coronary microcatheter from iVascular, recently received CE mark approval. The device was approved to...
First U.S. Patients Treated With OrbusNeich Teleport Microcatheter
News | Catheters | January 31, 2019
Cardiovascular Systems Inc. announced that the first patients in the United States were treated using the OrbusNeich...
Merit Medical Acquires Assets of Vascular Insights LLC
News | Catheters | December 18, 2018
Merit Medical Systems Inc. announced that it has acquired substantially all of the assets of Vascular Insights LLC,...
Reflow Medical's Wingman Crossing Catheter Receives FDA Clearance for Coronary Indication
News | Catheters | October 02, 2017
October 2, 2017 — Reflow Medical Inc. announced that the company has received 510(k) clearance from the U.S.
Roxwood Medical Announces Agreement With Abbott for U.S. Product Distribution
News | Catheters | August 09, 2017
Roxwood Medical Inc. recently announced it has entered into an exclusive agreement with Abbott for distribution of...
Teleflex, FDA 510k clearance, TrapLiner Catheter, U.S. launch
Technology | Catheters | March 02, 2017
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
Merit Medical Systems, SwiftNINJA Steerable Microcatheter, FDA 510(k) clearance
Technology | Catheters | November 09, 2016
November 9, 2016 — Merit Medical Systems Inc.
VentureMed Group, Flex Scoring Catheter, FDA approval, peripheral arterial disease, PAD, endovascular treatment
Technology | Catheters | July 13, 2016
July 13, 2016 — VentureMed Group Ltd., specializing in devices for the endovascular treatment of...
Roxwood Medical, MicroCross Catheter, full U.S. launch

Image courtesy of Roxwood Medical

Technology | Catheters | January 07, 2016
Roxwood Medical Inc. reported that more than 500 patients have been successfully treated as part of the initial limited...
Overlay Init