February 28, 2018
Real-World Results of VentureMed's Flex Catheter Presented at LINC
March 1, 2018—VentureMed Group, Inc. announced that early postmarket data of the company's Flex catheter were presented in three scientific abstracts at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.
According to the company, the data support the safety and efficacy of Flex as a vessel preparation device to facilitate the dilatation of stenoses in a variety of femoropopliteal lesions. The device creates continuous longitudinal microincisions to prepare vessels for angioplasty. Created as a one-size-fits-all device, Flex utilizes a basket equipped with three atherotomes that contour to the vessel wall. VentureMed stated that the real-world outcomes presented at LINC highlight the benefits of the Flex catheter.
The device creates a significant luminal gain before angioplasty without flow-limiting dissections, emboli, or perforation. The device has shown a low rate of minor dissections (5% in all cases), decreasing the necessity for stenting. Additionally, vessel wall compliance is greatly improved and a larger surface area for drug uptake is created. The Flex catheter is cleared for sale in the United States and has received CE Mark approval for sale in the European Union, advised VentureMed.
At LINC 2018, Louis Lopez, MD, presented multicenter acute results of 237 femoropopliteal lesions. Treated lesions were an average of 136 mm and included chronic total occlusions (CTOs; 43%), in-stent restenosis (8%), and moderate to severe calcium (51%).
In the company's press release, Dr. Lopez commented, "The angiographic results show that Flex safely achieved a luminal gain prior to angioplasty without flow-limiting dissection, perforations, or embolization. Additionally, low balloon inflation pressures were noted, suggesting improvement in the vessel compliance with use of the Flex."
Also at LINC 2018, Jihad Mustapha, MD, presented, "Early Clinical Results of the Flex Catheter in the Treatment of Below-the-Knee Lesions." The data analyzed acute results of 27 below-the-knee (BTK) cases, of which, 52% were CTOs. Flex demonstrated 100% technical success, defined as a luminal gain created before angioplasty, with an average luminal gain of 27%. There were no occurrences of flow-limiting dissections, emboli, or perforations. The data suggested that Flex is a useful device for treating BTK lesions.
Finally, Dr. Lopez presented a challenging case, "Recanalization of a Chronic Total Occlusion in a Popliteal Artery Using a Flex Scoring Catheter Prior to Drug-Coated Balloon." CTOs in the posterior and anterior tibial arteries were prepped with the Flex catheter before intervention with a drug-coated balloon. The posterior and anterior tibial arteries were successfully treated, creating a patent pedal arch without the need for stenting and with no adverse events, reported the company.