Earlier this year the FDA accepted LimFlow’s Percutaneous Deep Vein Arterialization system into its Breakthrough Device Program.
CEO Dan Rose is hopeful that that designation, along with an increased feasibility study size, will help get the company’s pDVA product to critical limb ischemia patients in the US facing limb amputations with no other options.
“There are over 270,000 ischemic major amputations in U.S. and Europe every year and these patients have no option today,” Rose said in an interview with MassDevice.com. “We’re really trying to provide a new solution for patients who have exhausted all their other options.”
Started in 2012 by Dr. Martin Rothman, LimFlow has had its sights set on treating end stage critical ischemia since formation, according to CEO Dan Rose.
The company’s flagship product, the pDVA system, is designed to restore perfusion to ischemic feet to relieve resting pain, promote chronic wound healing, reduce amputations and restore mobility. It uses ultrasound-guided catheters and covered nitinol stents to bypass diseased arteries and divert blood flow to the tibial vein to vascularize the affected feet.
“The concept of Limflow is to leverage the fact that, as we all know, you have an arterial tree that supplies blood to every part of your body, including your foot – you also have a venous tree that takes blood back to the heart,” Rose said. “What we do instead of using the highly diseased arterial tree is cross from the arterial vessel, typically the posterior tibial artery that leads right down into the foot, and cross from that artery into the vein.”
The procedure includes removing valves and veins to keep blood from flowing in the wrong direction, pushing blood through covered stents down into the foot to restore flow, Rose said.
“This allows your foot wound to heal and for you to avoid having a major lower limb amputation, which is highly associated with early mortality and extensive, expensive costs to hospital and healthcare systems, as well as loss of quality of life for patients,” Rose said. “No one wants to lose their limb. By healing the wound, we allow the patient to keep their limb and continue on.”
The device and associated procedure provides an option to individuals who had no option outside of amputations, Rose said, and has already been shown to be effective in early trials.
“This is the biggest advance I’ve seen for people at risk of amputation in my 25 years in practice. In the past, the only thing we had to offer these no-option patients was a segmental amputation of parts of their foot, and most patients ended up losing their entire foot,” Dr. Daniel Clair of Palmetto Health-USC Medical Group, who performed the 10th case in an ongoing feasibility study of the device said in a press release.
The system fills a role that’s difficult for existing technologies for treating peripheral artery disease to fill, Rose said. That’s because most of those technologies are based on earlier technologies made for treating coronary arteries.
“If you imagine in your coronary artery, you may have a lesion in your left anterior descending artery that’s eight millimeters long. You’re going to put a nine millimeter stent in and you’re going to cover that lesion and that lesion is not going to stenos again, and blood will flow through it for the rest of the patient’s life,” Rose said. “A lesion in your tibial artery could be 150 or 200 millimeters long – you’re talking about the artery that runs all the way down your calf right into your foot. The longer the lesion, the harder it is to keep open.”
Outside length, the location of the artery makes stenting a challenge, Rose said, as an unnecessarily rough impact could permanently crimp a stent there, stopping blood flow.
The system is already cleared in Europe, with commercialization underway, Rose said. The company is also running a large post-market study of the device in the region, which he said the company is focused on for the year, alongside its pursuit of FDA clearance.
“We have submitted to the FDA to get a clinical trial this year. We look forward to following up with them to confirm our approval to begin that trial. That’s the trial that will really be submitted for formal pDVA approval in the US,” Rose said.
Rose said the company has plan to begin enrollment in a full pivotal trial of the device by 2019.