Under the direction of CEO and Co-Founder Joseph Rafferty, VESTECK is revolutionizing endovascular aortic repair (EVAR) with its cutting-edge solution for endograft fixation. VESTECK’s mission is to develop advanced medical devices that set new standards for efficacy and patient safety.
Rafferty recalled being approached by two pioneering surgeons, Dr. John Edoga and Dr. Terry Richard, with a solution to a major issue they identified in aortic aneurysm (AA) repair. Rafferty recalls, “I’ve been in the cardiovascular/vascular surgical space for many, many years and wasn’t aware of the significance of the problem. There are about three million patients in the US that have AAs, with 80% of them repaired endovascularly—and evidently, the endovascular repairs are not a durable procedure, and I had no idea.”
Dr. Edoga and Dr. Richards approached Rafferty with their solution: a catheter preloaded with nitinol sutures to secure the graft to the aorta at the time of its initial implant and prevent it from leaking and migrating. After consulting with key opinion leaders worldwide, Rafferty discovered how grave the situation truly was. “If you talk to the high-volume physicians around the world, they're doing 80% of the complex procedures, and they're telling me that 40, 50, 60% of their patient population are complex redos where these procedures have failed,” Rafferty continues.
Rafferty shared, “I have a grandparent who died of an aneurysm. The more I researched this conversation with physicians I’ve been in the operating room with, the more the significance of this problem was reinforced for me.” Founded in 2019, VESTECK has a corporate office in Westchester, Pennsylvania and an R&D product development and manufacturing facility in Carlsbad, California.
The EVAR market is experiencing significant advancements and challenges as innovators work to address the growing population suffering from AAs. Rafferty highlighted, “About three million patients are diagnosed with AAs. Approximately one million patients around the world have these implants already—and they’re failing. The population of people over 65 years of age is growing exponentially. There are roughly 1.4 billion baby boomers worldwide, with 55 million here in the US. Sedentary lifestyles, cardiovascular disease, poor diet, obesity, and morbid obesity are growing in countries all around the world and certainly here in the US.”
From a competitive standpoint, the market offers limited alternatives to address the issue. Medtronic’s Heli-FX EndoAnchor is currently one of the few competing technologies, but Rafferty noted, “The challenge is that they’re very difficult to deliver due to their design, which was originally intended for hernia mesh fixation.” The issue with such devices stems from the aorta’s heterogeneous nature, as calcium and thrombus deposits can prevent proper sealing, rendering the device less effective.
Innovation is key to solving these challenges, with new devices being developed to deliver more precise repairs. As Rafferty pointed out, “Our device was designed to fit very easily into existing procedural workflows” with superior precision, speed, and safety. Unlike competitors’ bulk-delivered sutures, VESTECK’s technology allows for the placement of individual suture pairs. Rafferty explained, “Our competitors tend to want to deliver a ring of eight sutures at once. The challenge with that is if any one of those eight sutures were to hit calcium going in, the graft is not going to be sealed. Physicians tell us what they actually need is something that can deliver each individual pair of sutures so they can be very precise and safe.”
VESTECK’s innovation consists of two technologies: the Suture-Tight™ Catheter and the Suture-Tight™ Suture. Conceived by physicians, the Suture-Tight™ Catheter delivers preloaded sutures, securing EVARs/TEVARs to the aorta at the time of initial implant or repair procedures. The Suture-Tight™ Catheter is designed to precisely and rapidly deploy sutures with ease and to allow for the suture to be retracted and repositioned if necessary. With a single insertion, the physician can implant up to four sutures. The Suture-Tight™ Suture was designed from Nitinol to behave like a surgeon's suture; each endosuture works as a pair of surgical sutures.
In alignment with VESTECK’s physician-centric approach, the Suture-Tight™ Delivery System and Suture are designed to fit seamlessly into existing procedural workflows. Rafferty clarified, “We’re not tearing down an already established procedure; we’re augmenting it. We’re taking a good procedure and making it much more durable for patients; we’re giving physicians a tool to repair these failed ones.”
VESTECK has made substantial progress in developing and validating its Suture-Tight™ Delivery System and Suture. With its manufacturing facility in Carlsbad, the company has progressed from a prototype to clinical studies with “14 clinical cases on patients around the world,” demonstrating the device’s reliability and efficacy in diverse environments. These cases have been performed in Latvia, Canada, and Australia, with eight different physicians confirming the technology’s ease of use and success, independent of practitioner skills.
VESTECK is initially targeting abdominal aortic aneurysms (AAAs) but plans to address thoracic arch aneurysms by making minor modifications to the design. Based on feedback from physicians, VESTECK’s technology can potentially address issues with securing grafts in other locations, such as the iliac arteries and esophagus. Rafferty continued, “We have the platform, and we’ll start knocking off one once our clinical trial is underway and our development team can turn their attention to the next big thing, which will probably be the thoracic aorta.”
With promising clinical results from 15 preclinical studies, the company is currently in a design freeze and is ready to move forward with a 100-patient 510(k) clinical trial with plans to raise $16 million to fund the study in a Series B funding round.
According to LSI’s Global Surgical Procedure Volumes (SPV) database, nearly 212,000 AA procedures were performed in 2023. As the technology to detect at-risk aneurysms continues to improve, LSI projects that these procedures will increase at a CAGR of 3.5%, reaching approximately 251,900 procedures by 2028. In many of these procedures (approximately 1 in 4), patients will experience complications with their stent grafts, known as endoleaks.
The market for aortic stent grafts is expected to grow slightly slower than the projected growth in AA procedures. Downward competitive pricing pressure will restrain market growth throughout the 2023 to 2028 forecast period. Based on data from LSI’s Market Analysis and Projections (MAP) database, the global aortic stent grafts market is currently valued at $1.6B as of 2023 and will increase at a CAGR of 2.0% to $1.8B by 2028.
Above all, the implementation of screening guidelines for AA is integral in identifying patients with AA. When implemented properly, at-risk adults undergo an abdominal aorta ultrasound examination. Ultrasound has demonstrated extremely high sensitivity and specificity in correctly detecting and identifying AA. Ideally, proper implementation of screening guidelines would result in corresponding increases in procedure volumes and market size for the treatment of AA.
Rafferty has been selected to present at LSI Europe ‘24 this September 16th-20th in front of hundreds of global medical technology companies. Join us in welcoming Rafferty to the event in Sintra, Portugal, where he will share the latest updates on VESTECK’s technology and development.
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