Better than Shockwave? AVS thinks its intravascular lithotripsy design has a big advantage

2024-06-18

Johnson & Johnson MedTech’s $13.1 billion deal to buy Shockwave Medical is bringing even more attention to intravascular lithotripsy (IVL) technology and the device developers working on it. Amplitude Vascular Systems (AVS) recently won investigational device exemption (IDE) from the FDA to study its Pulse IVL system before filing for regulatory review, following Shockwave’s lead. “They’re currently the only one in the market [and are being] acquired by J&J for gobs of money. But the landscape is pretty interesting,” said AVS Executive Chair Mark Toland. In an interview with Medical Design & Outsourcing, Toland — who is also CEO of microsurgical robotics developer Medical Microinstruments Inc., a Moon Surgical board member and former president and CEO of Corindus Vascular Robotics (sold to Siemens Healthineers for $1.1 billion in 2019) — discussed the different technology approaches to IVL and why he thinks the AVS Pulse system has an engineering advantage. “Shockwave is using popping bubbles to create a sound wave,” Toland said. “They emit electricity down to these emitters that creates a bubble effect — cavitations — and then they pop, creating a sound machine to give them peak pressures.” The AVS Pulse technology, on the other hand, “eliminates the electrical current to emitters and uses CO2 via a water hammer effect to generate pressure waves and essentially pulse the balloon-like hydraulics,” he said. Previously: AVS is developing a new method of intravascular lithotripsy Then there’s the laser approach taken by Bolt Medical and FastWave Medical, but medtech lasers “are a little tricky,” Toland said. “I don’t like laser,” he said. “Now, I’m not talking about just Bolt or FastWave. I don’t like working with lasers. It’s hard to reproduce and make, and particularly when you’re trying to control a laser that’s going a long direction down a little, small, tiny catheter, because in order to create the energy, you’ve got to stop the laser into a wall that you create in the catheter, and it has to hit that wall and then create some sort of cavitation or heat and that’s hard. To make that and then make it cost effectively without it being the size of a refrigerator is really hard to do.” ‘Shockwave effect’ starts lithotripsy rush Lithotripsy has long been used to treat kidney stones, and Shockwave applied that approach to treat calcification in diseased arteries. Intravascular lithotripsy creates pressure to crack calcification that’s nearly as hard as bone, expanding the artery to improve the performance of stents. Shockwave is the only device developer with FDA approval for IVL to treat coronary artery disease (CAD) and peripheral artery disease (PAD). “What’s happening in the space right now is that there’s a lot of these technologies that are starting to call themselves lithotripsy because of the Shockwave effect,” Toland said. “We really think lithotripsy gets defined a lot by peak pressure waves. In other words, you’re not just generating pressure, you’re generating peak pressure waves, some sort of energy coming down to the treatment zone.” “Think of it like a roller coaster, where you need a peak of a pressure wave, and then it goes back down, and it peaks again and goes back down,” he continued. “That’s what Shockwave does. That’s what we do. You’re delivering 50 atmospheres of pressure at the peak, and then it will dissipate and then hit it again, and it’ll dissipate and hit it again … a bit like a jackhammer.” Does AVS have an advantage over Shockwave? AVS co-founders Dr. Hitinder Gurm and Robert Chisena (who’s also chief technology officer) saw an opportunity to improve on Shockwave’s approach, Toland said. Using CO2 as an energy source to create a water hammer effect rather than electrical components could improve an IVL catheter’s ability to navigate a patient’s blood vessels. The Pulse system design’s omission of electronic emitters is a big advantage over Shockwave’s technology, he said. “We think there’s some design principles with the electronic emitters that you’ll never be able to get over,” Toland said. “If you wanted to try to make it smaller, or you wanted to make it more deliverable to get around corners, it’s very difficult to have electrical components in a catheter. They’re just stiff. By removing the electrical components, we think we’ll have an ability to snake around bends easier.” Another big advantage Toland said AVS has over Shockwave is in capital equipment costs for customers. “We don’t have a huge console expense,” Toland said. “We do provide a GUI (graphical user interface) for the user with some compliance data, but no super-expensive console.” What’s next for AVS Following the recent verification and validation (V&V) of the AVS Pulse system’s console, handle, amplifier and catheter, Toland said the FDA approved its IDE request surprisingly fast, giving it an unconditional green light in 30 days instead of the anticipated 90 days. “That means we’re going to be treating U.S. patients this summer,” Toland said. “We’ve already got 20 sites up and running and ready to enroll fast.” AVS plans to seek FDA 510(k) clearance for treating PAD using Shockwave’s technology as a predicate, and then to do the same for CAD “right on the heels of that” first clearance. “We worked with the FDA to make sure they understood our mechanism of action during our Q-Sub, and then during this IDE we went back and forth with a lot of great questions from them and us,” Toland said. “This indication is super important to be an indication for intravascular lithotripsy, because that flows right into the existing reimbursement landscape … that Shockwave created.” AVS expects the clinical trial to run over the next six to 12 months, including six months of follow-up. The company would then file for 510(k) clearance for PAD and hope for good news in late 2025 or early 2026. Winning indications for both PAD and CAD would be “a competitive win,” and AVS has a plan that it hopes will result in its first-in-human CAD procedure around end of 2024. But it will have to persuade the FDA to move fast on that CAD first-in-human. “We feel like we’ll be pretty successful with that negotiation because the console, the handle and the amplifier — all the stuff that controls the pulsing — it’s the exact same technology that we’re using in the peripheral trial, so they’ve already seen it and they’ve already seen our bench testing,” Toland said. “The only thing we’ll have to insert into our coronary IDE submission is the catheter design, and we’re working on that right now. We’ve already moved it into development stage, but because we’ve already got three out of four of those that have gone through V&V on the coronary side with the FDA, to us that feels pretty good.” “We’re moving pretty quick,” he continued,” and I think a lot of that is attributed to us really building up the strong fundamentals of what a company and what a what a product build looks like, the FDA feels comfortable that we’ve held ourselves to the rigorous standards that they demand.” Related: Medtech vet Sean Gilligan’s tips and red flags for vetting suppliers