Boston Scientific Leads the IVL Competitive Surge as Rivals Close In on Johnson & Johnson

Bolt Medical on Self-MediaAnnounced that its IVL product --- Seismiq has been launched this monthThe completion of the first batch of commercial cases in the United States marksSeismiqOfficially InvestedTreatment of Suprainguinal Peripheral Artery Disease (PAD) Lesions. President of Boston Scientific's Peripheral Vascular BusinessCatherine Jennings"As Seismiq initiates limited market release, we will focus on clinical practice and experience accumulation, ultimately promoting the widespread application of this therapy."

SeismiqBy generating laser acoustic pressure waves within the balloon catheter, it can break up both superficial and deep calcified plaques in the arterial vessel wall while protecting the surrounding soft tissue.

Boston Scientific regards Seismiq as a new generation of IVL system. All emission stations on its balloon can provide stable acoustic output and real-time feedback on treatment effects, without the need for sterile bag encapsulation of the handle.

Note:Boston Scientific Acquires Bolt Medical in January 2025Bolt IVL Technology, followed by BoltIVL Renamed to Seismiq, Used for TreatmentPeripheral Arterial Disease Above the KneeSeismiqTo gain FDA approval in early 2025. Additionally, for below-the-knee use.Peripheral Artery Disease and Coronary Heart DiseaseSeismiq is in clinical trials.

Johnson & Johnson: Maintaining Leadership in the IVL Market

Johnson & Johnson (Shockwave) has dominated the IVL market for many years.ShockwaveChief Medical OfficerNick West stated that he is not concerned about the competition brought by multiple companies testing or developing IVL systems.ShockwaveLeading competitors by a decade in terms of clinical usage experience and data accumulation.

Shockwave IVL has been approved by the FDA for PAD and coronary artery treatment.ShockwaveIs committed to expanding more anatomical sites and indications.Nick WestSaid: "Currently, our penetration rate in coronary surgeries has exceeded 10% (this data does not include peripheral vascular applications)." As of nowShockwave IVLAchieving the Significant Milestone of Treating One Million Patients

Progress of Other IVL Competitors

Current potential competitors developing IVL products include Abbott, Philips, as well as FastWave and Amplitude Vascular Systems, among others.

Acquired by Abbott in 2023Cardiovascular SystemsThe IVL product under development will be obtained at that time, and the TECTONIC CAD IVL pivotal study will be initiated in 2025. The trial will test Abbott's Coronary IVL System for treating severely calcified stenotic coronary arteries in 335 patients across 55 centers in the United States, with an expected completion date of June 2028.

Philips Launches U.S. THOR Pivotal Clinical Trial in Fall 2024 to Evaluate Efficacy of Its Catheter Combining Laser Atherectomy and Intravascular Lithotripsy for PAD, with Completion Expected by End of 2027.

FastWave plans to Artero peripheral electric IVL (E-IVL) Launch pivotal clinical trial in the United States.

Amplitude Vascular Systems' Pulse IVL is currently conducting the POWER PAD 2 study, with 120 patients enrolled across 20 clinical centers. The study is expected to be completed in March 2026.