Boston Scientific
(NYSE: BSX)
has received FDA clearance for its Bolt intravascular lithotripsy (IVL) system, according to the FDA’s 510(k) database.
According to the FDA, it granted 510(k) clearance for the system on March 25, about two months post-submission (Jan. 27).
The database included the RESTORE ATK (above the knee) trial for Bolt IVL in treating stenotic lesions. According to the trial’s information provided on ClinicalTrials.gov, the study of 97 subjects was completed in July of 2024. That conclusion came about six months before Boston Scientific agreed to acquire Bolt Medical and its IVL technology. Boston Scientific initially developed the concept for the Bolt IVL system, helping establish Bolt Medical in 2019. As a strategic investor, the Marlborough, Massachusetts–based company already has an equity stake of approximately 26%.
Bolt IVL was designed to enhance percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium prior to full balloon dilatation at low pressures.
The advanced laser-based platform treats of 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.
BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang continue to rate Boston Scientific as a “Buy” and were excited by the Bolt system’s clearance.
“We are pleasantly surprised to see the Bolt IVL system get this clearance so quickly via the 510(k) pathway,” the analysts wrote. “We believe (again, trying to confirm with BSX) the system remains under FDA review for below the knee. It is also currently being evaluated in the FRACTURE IDE study for the treatment of coronary arterial disease with severely calcified lesions.”
More about the IVL space as Boston Scientific brings its tech to market
Boston Scientific made waves with its foray into IVL with the Bolt acquisition at the start of the year. The hot space continues to expand with players of all sizes attempting to gain share.
Johnson & Johnson currently leads the way after its 2024 acquisition of IVL leader Shockwave Medical. Other companies, such as FastWave Medical, Vantis Vascular and Amplitude Vascular are making waves in IVL, too.
Abbott received FDA IDE approval for its coronary IVL system last week, adding another big name in medtech to the fray.
