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Boston Scientific’s $664m bet on Bolt Medical has paid off, as the company’s intravascular lithotripsy (IVL) system gains US Food and Drug Administration (FDA) clearance.
Whilst neither Bolt Medical nor Boston Scientific have publicly unveiled the clearance, the FDA’s database lists a 510(k) decision date of 25th March.
Boston Scientific helped establish Bolt Medical in 2019 and has held a 26% stake in the company since. Following promising results for the company’s IVL technology, Boston Scientific agreed to acquire a remaining 74% stake in a deal worth up to $664m in January 2025.
IVL uses sound waves to break up calcified portions of vessels. The high-frequency, pulsatile pressure fragments calcium lesions using a balloon-based system and helps restore vessel patency.
Andrew Thompson, director of therapy research and analysis for medical devices at GlobalData, says that the clearance will see Boston Scientific consolidate its market position given its “already a major player in the percutaneous transluminal angioplasty (PTA) balloon catheter and percutaneous transluminal coronary angioplasty (PTCA) markets.”
A Boston Scientific spokesperson said the company does not have additional comment on the clearance.
The FDA 510(k) database lists RESTORE ATK clinical trial (NCT05662787) as evidence supporting the clearance. The trial, which enrolled 95 patients to assess the Bolt IVL system in treating stenotic lesions, met its primary safety and efficacy endpoints.
The system was also being evaluated in the RESTORE BTK trial in 20 patients with moderate to severe calcified infrapopliteal arteries. This trial also met its primary safety and efficacy endpoints.
Johnson & Johnson brought attention to the space last year when it acquired Shockwave Medical in a $13.1bn deal – still the largest ever deal in the medtech industry to date. Though the buyout, J&J gained access to the Shockwave IVL systems and, until Bolt Medical’s clearance, was the only FDA-approved system on the US market.
Thompson says that Shockwave leads the way in terms of IVL technology. The company’s revenue for Q1 2024 was $218.8m, a 36% increase from the same period in 2023. The company previously projected full-year revenue in the range of $910m $930m for 2024.
Both J&J and Boston Scientific have since doubled down their presence in the market, which is a segment of the atherectomy device sector, forecast to grow to over $2bn in value by 2034, as per analysis by GlobalData.
Abbott is eyeing the sector too, receiving an investigational device exemption (IDE) from the FDA to initiate a trial with its coronary IVL system. Abbott’s TECTONIC trial will evaluate the yet unnamed system for the treatment of severe calcification in coronary arteries before implanting a stent. A total of 335 people are expected to be enrolled across 47 sites in the US. There are also numerous smaller companies developing IVL technology.