Manny Villafaña pulls open a small drawer, pokes through what looks like a nest of slinky little worms, and gently picks out a prime specimen of his latest medical device: the eSVS Mesh.
The silvery mesh tube lies across his fingers; it’s about eight inches long, almost silky to the touch. It’s made of Nitinol, an alloy of nickel and titanium that has shape memory, meaning it always returns to its original shape after being deformed. That allows it to act like “support hose” of sorts, fitting snugly around the vein grafts used in coronary artery bypass graft (CABG) surgery and helping them last longer. Without support, nearly half of vein grafts fail after a few years. Sometimes, they have to be replaced with a repeat surgery.
Villafaña is widely known for his pioneering development and commercialization of medical devices. In 1972, he formed Cardiac Pacemakers, Inc., (now part of Boston Scientific) and developed the first pacemaker powered by a lithium battery. It can last for decades, compared with the 12-to-24-month life of mercury-zinc batteries that were standard at the time. In 1976, he started St. Jude Medical, which designed the first bileaflet mechanical heart valve, an improvement over the era’s single-occluder valves because it greatly reduced the occurrence of blood clots.
His new eSVS Mesh seems elementary by comparison. It has no moving parts, no batteries or electronics or robotics, no drugs to dispense.
Still, “this technology has a greater potential than anything I’ve done before,” Villafaña says. Numbers to back up the assertion are quick off his tongue: Each year, patients throughout the world receive 50,000 to 75,000 defibrillators, 250,000 tissue and mechanical heart valves, 500,000 to 600,000 pacemakers, and 750,000 stents. But about 800,000 coronary bypass procedures are done annually, requiring on average 2.3 vein grafts each.
“That’s a 1.8 million market potential for us!” he says.
“Us” is privately held Kips Bay Medical, the Plymouth-based company that Villafaña formed in 2007 to develop the eSVS Mesh for regulatory approval and commercialization. “We don’t have any competition,” he says. “If I were to develop a new pacemaker or new heart valve, I would be going against really tough terrain, with 10 to 30 competitors. But the mesh is absolutely brand new, and every surgeon I’ve talked to wants to see it and get involved with it.”
Veins “Blow Up Like a Sausage”
To the extent that heart surgeons are intrigued by the eSVS Mesh, it’s easy to understand why. For 50 years, they’ve been giving heart disease patients a new lease on life with coronary artery bypass graft surgery—but with mixed results.
