Symposium Highlights Emerging Technologies in Endovascular Therapy

Hollywood, FL (January 22, 2020) -- The rapid advance of technology was the focus of a morning session on the first day of the International Symposium on Endovascular Therapy (ISET).

Constantino S. Peña, MD, FSIR, Miami Cardiac & Vascular Institute, introduced the audience to Fiber Optic RealShape (FORS) technology (Philips) that uses light instead of x-ray and makes catheter and wire motion possible without fluoroscopy. Dr. Peña explained how the technology shows the catheter and guidewire in 3D in real-time, with distinctive colors and unrestricted viewing angles. To conclude his presentation, he reviewed the FORS First Clinical Study, which demonstrated the feasibility of using FORS technology in endovascular procedures.

Robert Beasley, MD, Mount Sinai Medical Center, updated the audience on another new technology, the MicroStent (Micro Medical Solutions), a microvascular stent with a proprietary platinum core design. “The platinum core makes a difference as far as seeing this stent,” said Dr. Beasley. He reviewed the results of the MicroStent U.S. feasibility study, which showed excellent safety and efficacy data, with a 12-month primary patency of 90.9%. The delivery system and flexible stent design led to 100% delivery success, he noted. Dr. Beasley said he is “enthusiastic about start of the pivotal STAND study [Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in Subjects with Arterial Disease Below the Knee] and results, as well as the forthcoming data from the HEAL study.”

With the next presentation, the focus of the symposium shifted to atherectomy. “One should be selective in the decision of whether or not to use atherectomy, and individualize the choice of device to the patient,” said D. Chris Metzger, MD, Ballad Health System CVA Heart and Vascular Institute. He shared practical tips for using orbital atherectomy (CSI), the Jetstream atherectomy system (Boston Scientific), Turbo Tandem Laser (Spectranetics), and SilverHawk directional atherectomy (Medtronic).

“Appropriate device selection and meticulous technique are needed for atherectomy success,” he concluded.

Creation of arteriovenous (AV) fistulas is another area that presents clinical challenges. Alex Powell, MD, FSIR, Miami Cardiac & Vascular Institute, explained the issues surrounding surgical fistulas and introduced the audience to new devices, the Ellipsys vascular access system (Avenu Medical) and the WavelinQ 4F endoAVF system (BD). “There is quite a bit of initial excitement about these two devices that create a percutaneous fistula,” said Dr. Powell. Current data on the devices are early, but hold the promise of potentially improved fistula outcomes. Performing endovascular AV fistula procedures is within the skillset of most interventionalists, noted Dr. Powell, but requires refining technical skills and gaining greater knowledge of forearm venous anatomy.

Daniel Clair, MD, Palmetto Health, University of South Carolina School of Medicine, shared the results of the LimFlow System (LimFlow) in the PROMISE I trial. The LimFlow System is a novel, safe, and reproducible approach for treating patients with no-option CLI. It may improve wound healing rates and reduce amputation rates in a population for whom amputation would otherwise be considered inevitable, and initial findings from this early feasibility trial are “very promising,” said Dr. Clair. He added that enrollment has been initiated and is ongoing in a pivotal trial.

Continuing the conversation on emerging technologies, William A. Gray, MD, FACC, FSCAI, Main Line Health, described how the paclitaxel controversy has opened the door to the consideration to alternative therapies, including limus coated and eluting technology. Results of the TANGO trial (studying the effects of Mercator’s proprietary Bullfrog Micro-Infusion Device in lesions below the knee in critical limb ischemia patients) are positive, both for primary and secondary endpoints, and warrant continued investigation, he said. Sirolimus and its analogues have pharmacokinetic challenges in its “natural” state, but delivery modifications can overcome those challenges. Future therapies include resorbable scaffolds as a delivery mode, he noted.

Delivering various endovascular therapies inevitably involves radiation, and Lindsay Machan, MD, FSIR, Vancouver Hospital, in his presentation “New Technologies for Radiation Protection”, shared innovative ways to protect operators and staff from exposure to radiation. Triple-layer shielding with tungsten, antimony, and bismuth may help to reduce the impact of exposure, while artificial intelligence-enabled active coning may help to reduce radiation output. One novel biological strategy involves taking an antioxidant drink before a procedure in order to help to prevent DNA damage during an endovascular procedure.

Overall, “there are significant advances in development, but it’s important to remember that all devices are tested in optimized, non-real-world conditions. There is no safe [radiation] dose,” Dr. Machan said.

Barry T. Katzen, MD, FACC, FACR, FSIR, Miami Cardiac & Vascular Institute, concluded the session with a discussion of disposable robotic microcatheters (EndoWays). This innovative robotic technology has the goal of precision catheterization, with improved steerability and trackability. Other advantages include a reduction in radiation exposure for operators. Robotic, self-propelling microcatheter technology has diagnostic and therapeutic application potential. “One of the things that we found interesting was that [the EndoWays robotic microcatheter] is disposable, potentially approximately the same cost as a current microcatheter system, without the capital expense,” he noted.

“The use of robotics in the delivery of healthcare is growing,” Dr. Katzen said. The technology is promising and companies are keen to tackle the challenge of robotic surgery platforms to be used throughout the body. Dr. Katzen noted that over 84 companies are now focusing on robotic surgical platforms for use in various areas throughout the body.