Dr. Michael R. Jaff, chief medical officer and VP of Peripheral Interventions at Boston Scientific, shared the news of the first IVL (intravascular lithotripsy) patient treated in the registry on LinkedIn.
The ELEGANCE registry evaluates real-world outcomes with drug-eluting therapies. Those include the company’s Ranger drug-coated balloon and Eluvia drug-eluting stent. It evaluates these systems in a population including at least 40% women and 40% pateints from underrepresented racial and ethnic groups.
Boston Scientific said that adding Seismiq cases to the registry further expands the understanding of how to optimize treatment for peripheral artery disease (PAD) in everyday clinical settings.
Dr. Max Arroyo treated the first IVL patient in the registry at St. Bernards Medical Center in Jonesboro, Arkansas.
“This milestone reflects strong collaboration across our clinical, operational and site teams to bring this cohort to life and begin generating much needed data in this unique prospective registry,” Jaff said. “As we expand enrollment in the SEISMIQ IVL cohort, we look forward to supporting additional sites in reaching their milestones and advancing evidence generation in PAD management.”
More about the Boston Scientific Seismiq system and IVL
Last year, Boston Scientific entered the IVL space last year with the acquisition of Bolt Medical for up to $900 million. The Seismiq system, Bolt’s next-generation IVL technology, received FDA clearance just before the deal closed and is now in a limited U.S. rollout.
The advanced laser-based platform offers a treatment for both coronary and peripheral artery disease. Its novel application of lithotripsy fractures calcium by creating acoustic pressure waves inside a balloon catheter. The system also includes visible, directional emitters for consistent energy delivery in the treatment of calcified lesions.
CEO Mike Mahoney and Chief Medical Officer Dr. Ken Stein outlined future plans for the IVL technology at the J.P. Morgan Healthcare Conference in San Francisco earlier this year. Boston Scientific already initiated a limited market release for Seismiq in above-the-knee procedures. It also finished enrollment in the FRACTURE trial, which evaluates IVL in coronary artery disease (CAD). The company expects results in the second half of this year.
Boston Scientific hopes to make inroads as the IVL space, led by J&J since its $13.3 billion acquisition of Shockwave Medical in 2024, continues to heat up. Stryker just completed an acquisition of Amplitude Vascular Systems last week to add further potential competition.
Abbott also has its own IVL system in the works, while FastWave Medical, Elixir Medical and Vantis Vascular advance their own platforms.
