When a cardiovascular intervention is called for, a less-invasive solution is always preferred – which is why percutaneous procedures, such as transcatheter aortic valve replacement (TAVR) and endovascular aneurysm repair (EVAR) are on the rise.
But this trend hasn’t been without its drawbacks, as cardiologists and surgeons are now faced with the challenge of closing relatively large femoral access sites – ranging from three to eight millimeters in size – that are required to conduct these procedures. Closure devices that are currently in use were not designed for large bore access sites, and in some cases can increase procedural invasiveness when they fail to close a vessel. In this scenario, a vascular surgeon is called in to remove the failed suture or device and repair the artery with an invasive, open procedure.
That is, until now, as Lume Medical introduces its minimally invasive large bore closure device that will address these current challenges.
Identifying a need
The newest startup to join the Fogarty Institute, the Lume Medical team, comprised of co-founders Eric Kramer, Ph.D., Vivian de Ruijter, MD, and Katie Blevins, MD, Ph.D., originated from the Stanford Biodesign program. They are aiming to make their technology the standard for percutaneous femoral vascular closure.
Their vision stemmed from observing the complications that resulted from current large bore closure techniques, including infection, pseudoaneurysm, extended hospital stays and post-operative pain. These complications are particularly prevalent among patients with severely calcified femoral arteries, who represent two-thirds of patients over 70 and who don’t currently have a minimally invasive closure option. While many companies have looked to address these problems, the answers so far have only met a subset of the need.
Meeting growing market demand
The market is primed for this type of technology. Currently, more than half a million large bore procedures are conducted each year – up to 200,000 of which are performed on patients with severe anterior calcification, representing an initial market opportunity of more than $500 million.
Lume’s technology seeks to reduce hospital costs while improving patient care. The team has already accomplished several key milestones, including filing for IP protection, refining their prototype and completing several feasibility studies. They are currently preparing for their first in-human study and raising funds to further advance their technology.
The team offers diverse, yet complementary, skillsets, with Eric focusing on design, prototyping and manufacturing; Vivian on reimbursement and business strategy; and Katie on surgical and regulatory strategy and clinical studies.
“Stanford Biodesign was critical in helping us clearly define our clinical need and designing a solution compatible with value-based care, which allows for a better result at less cost,” said Eric. “The Fogarty Institute will now take us to the next step, providing us the tools to implement our technology and accelerate our time to market. We are looking forward to working with the Institute’s seasoned mentors and El Camino Hospital’s highly regarded physicians and anticipate benefiting greatly from interactions with both groups.”