Many ventures at Fogarty Innovation start with a defining “lightbulb moment,” and PQ Bypass, among the initial companies to emerge from Fogarty Innovation, shares a parallel journey. Following its acquisition by Endologix, a key player in vascular disease treatment, the company is now experiencing the gratifying results of its dedicated efforts. Their innovative device, the Endologix Detour System, is currently being deployed at El Camino Health, contributing to the treatment of patients suffering from complex peripheral arterial disease (PAD).
Dr. James (Jim) Joye, the PQ Bypass co-founder, experienced his “lightbulb moment” while engaged in consulting for various device companies. This experience, coupled with his desire to avoid the morbidity associated with open femoral-popliteal bypass surgery, served as the catalyst for the development of the startups’ percutaneous bypass concept.
PAD is caused by atherosclerosis, which narrows and blocks arteries, most commonly in the legs. If left untreated, it often leads to severe disability and amputation. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 18 million people in the U.S. suffer from PAD, which is particularly prevalent in individuals over the age of 60.
A pioneering technology that allows for safer procedures
Joye and fellow physician, Rich Heuser, a cardiologist in Phoenix, created what became PQ Bypass. Like most startups, it involved pooling limited resources and securing angel support to facilitate the launch. They hired engineers, obtained proof of concept and embarked on their journey.
During that period, Joye simultaneously served as the CMO of what was then the Fogarty Institute. Reflecting on that time, he notes that the institute provided an excellent environment for stimulating discussions, with Dr. Fogarty offering valuable assistance in advancing their technology. Another startup present at that time, HeartFlow, was also pioneering its technology, serving as a constructive partner for exchanging ideas.
Today, the Detour System has become an important clinical advance in the vascular field. “In medicine in general, and certainly in the cardiovascular space, there’s a desire to take what had previously been major, complex surgeries and convert them to minimally invasive procedures that accomplish the same or better outcomes, but are safer for the patient,” Joye said. “We’re fortunate to be alive in this era where we’ve seen coronary stents transform patients who used to require an open procedure.”
How it works
Joye explains that he uses the body’s natural plumbing system as a mechanism to create a bypass around long segments of occluded, severely diseased superficial femoral arteries. The procedure and technology have garnered significant interest from physicians who are eager to incorporate it into their practice due to its effectiveness in addressing a substantial unmet need.
Describing it as a “really slick device,” he notes the challenges associated with the conventional “gold standard” for treating extensive lesions, namely open surgery, where recovery poses difficulties and durability has been a notable concern. The Detour System’s innovative, fully percutaneous femoral-popliteal bypass solution is revolutionizing this landscape, with anticipated long-term patency rates exceeding 90%. “It’s truly a dramatic shift in terms of outcomes for the patient,” Joye said.
Enjoying a full-circle moment
The Detour System was recently introduced at El Camino Health, marking a significant milestone. The launch holds a special significance as Joye has been a part of the hospital team since 1998 and the location also served as the center for early prototype testing, as well as animal and cadaver work conducted in the early days of PQ Bypass. “My ideas and early tinkering with this procedure happened at El Camino, so now as it comes to life 20 years later, it has been especially fun to share it with some of the cath lab staff who remember the old days when we were perfecting it,” said. “To have them now as part of the finished product is extremely rewarding.”
In another full circle moment, Heather Simonsen, who served as president of what then was PQ Bypass, is now embedded in Fogarty Innovation as CEO of Boomerang Medical. “Heather played a crucial role in the success of PQ Bypass, and it’s been really fun to see her continue to blossom and positively impact the healthcare sector,” he noted.
A bright future for innovation
While new companies often hope to get momentum early on, Joye notes that persistence is a key attribute. “It takes about 10 years for companies to go from their start to being a commercial entity, so between success stories like HeartFlow and PQ Bypass, we’re starting to see the early wave hit the commercial market,” he says.
And since the number of companies that have been fostered through the vision of Fogarty Innovation has grown exponentially, he knows there are more successes on the horizon. “I’m really excited to see Fogarty Innovation continue to blossom and bring this constant flow of new technologies to improve patient care.”