Rolling Out the Biocarpet

Biocarpet

A team of University of Pittsburgh researchers is one step closer to clinically developing a revolutionary treatment for peripheral artery disease — with a design that takes inspiration from your living room carpet.

Jonathan Vande Geest, professor of bioengineering in Pitt’s Swanson School of Engineering, was recently awarded a three-year, $1.2 million Catalyze grant from the National Heart, Lung, and Blood Institute (NHLBI). His project “Biocarpet: The Next Generation Endovascular Device for Peripheral Arterial Disease” will finalize the design and prototype of a fully biodegradable electrospun sheet to treat peripheral artery disease (PAD) and progress toward clinical translation.

According to Co-PI and Distinguished Professor of Bioengineering William Wagner, the team took inspiration from an unlikely source in naming the device: carpet storage. 

“If you've ever been to a carpet store, you know they have big spools of carpet that they can unwind,” Wagner said. “When we insert Biocarpet into the body on the catheter, it looks like those rolls of carpet, and then it unfurls as it opens up inside the artery.” 

Nearly ten million people age 40 and older in the U.S. suffer from PAD; left untreated the disease can cause limited mobility, heart attack, stroke, and limb amputation. Patients with PAD suffer from reduced blood flow to their arms, legs, and pelvis due to narrowed or blocked peripheral arteries, but common treatments like stents lack the flexibility to hold up to the mobility of the body’s joints. 

“Unlike many places in the body, peripheral arterial disease affects arteries that cross joints.” Vande Geest said. “As a result, stents which are delivered endovascularly don’t do well and often fail due to fracture or re-narrowing. This occurs even in straight arteries that don't bend.” 

Other treatments for severe cases of PAD include balloon angioplasty and vascular bypass. Currently, there is no effective endovascular treatment option for blocked arteries at joint locations in the leg, hip, and knee, and according to Vande Geest, his team’s Biocarpet technology is an ideal, minimally invasive solution compared to stents. 

“Stents are common, but they impose a mechanical disadvantage which contributes to failure of the device post implantation,” Vande Geest said. “Our biodegradable device conforms to the patient’s artery and naturally disappears in the body, so we believe that endovascular treatment of peripheral stenotic disease will be revolutionized by this technology.” 

Vande Geest is also collaborating with Visiting Research Assistant Professor of Bioengineering Ali Behrangzade, University of Wisconsin Assistant Professor Dhanu Shanmuganayagam, and UPMC interventional cardiologist and Pitt School of Medicine Associate Professor John Pacella.  For Pacella, Biocarpet technology will significantly reduce the number of open surgeries he has to perform on patients with PAD. 

“When I perform an angiogram on a patient and find blockages in the femoral or popliteal arteries, both of which span joint spaces and undergo flexion and extension, we refer these patients for open surgery to remove the blockage,” Pacella said. “Biocarpet is a novel tool that provides an endovascular solution to relieve these blockages to improve blood flow, without open surgery.”

Biocarpet is also advantageous for patient recovery and ease of potential reintervention in the artery.

“Overall, opening blocked arteries with Biocarpet is much easier on the patient than open surgery because recovery is faster and the chance of infection is markedly reduced,” Pacella said. “In contrast with standard stents, even the possibility of re-intervention in the future is made easier because Biocarpet completely biodegrades, leaving no residual material in the blood vessel.” 

Biocarpet is composed of an electrospun polymer sheet, which will thermoform to match the shape of each patient’s artery and eventually biodegrade within the body. According to Wagner, the Catalyze grant will provide essential funding to transition the concept from inside the lab to treating patients.  

“This grant provides crucial expertise on manufacturing, preclinical testing, and more, depending upon what we need.” Wagner said. “Now that we have the proof of concept, we want to start moving toward a finalized design and start figuring out what we have to do to get to clinical trials.” 

For Wagner, developing Biocarpet is a testament to the strength of Pitt’s collaborations and is part of a larger trend towards translating research to clinical applications, both in Pittsburgh and around the country. 

“I think Pitt is also in a great position to do this kind of work because we have such strong connections between health sciences and engineering,” Wagner said. “These kinds of grants are really important because people and patients everywhere want to see the health outcomes that come from government-funded health research.” 

With the market size for patients with stenotic vessels traversing the knee that require an endovascular device estimated at about $250 million, the research team plans to commercialize Biocarpet with their company EV2 Technologies, Inc, which was co-founded by Vande Geest, Wagner, Pacella and Behrangzade in 2022. While they are focusing on the peripheral arteries for now, the Biocarpet technology could eventually be used throughout the body to treat other vascular diseases, according to Pacella.

“I envision many advantages to using a non-permanent device like Biocarpet to scaffold the artery open, even in the carotid or superficial femoral arteries,” Pacella said. “If Biocarpet is found to be effective, it would be just the tip of the iceberg and potentially game changing for the treatment of peripheral arterial disease.”