The US Food and Drug Administration (FDA) has granted Abbott an investigational device exemption to evaluate the company’s coronary intravascular lithotripsy (IVL) system in a clinical trial.
The 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.
Go deeper with GlobalData
IVL uses sound waves to break up calcified portions of vessels. The high-frequency, pulsatile pressure fragments calcium lesions and helps restore vessel patency.
Though brief on details, Abbott system follows a similar technical vein to other IVL devices. The company says its investigational system uses high-energy sound pressure waves to treat calcium blockages and potentially allow for better stent placement.
Abbott’s trial arrives in the wake of a growing IVL market. Johnson & Johnson has a FDA-approved technology, gaining access to the Shockwave systems through a $13.1bn acquisition of Shockwave Medical in 2024 – still the largest ever medtech deal to date.
Both J&J and Boston Scientific have since doubled down their presence in the market, the newest part of the atherectomy device sector is forecast to grow to over $2bn in value by 2034, as per analysis by GlobalData. Boston spent $664m to acquire IVL specialist Bolt Medical in January this year, whilst J&J expanded its product range with the launch of the Shockwave Javelin Peripheral IVL Catheter.
There are multiple early-stage companies developing technology in the field too, including Amplitude Vascular Systems and Elixir Medical, both of whom have reported positive clinical data.
IVL is being used for coronary and peripheral artery disease, with the former being the more common type of heart disease, affecting 1 in 20 adults in the US.
Abbott’s divisional vice president of global clinical affairs at Abbott’s vascular business, Jennifer Jones-McMeans, said the clinical trial with its new system is exploring the next generation of calcium modification technology and advancing the company’s portfolio of coronary artery disease treatments.
The IVL trial initiation comes months after Abbott’s orbital atherectomy system failed a trial in October 2024. The Diamondback 360 system, acquired in a $890m buyout of cardiovascular specialist CSI, showed no difference in treating calcified lesions compared to balloon angioplasty.
Abbott generated $42bn in revenue for 2024, a 4.3% rise from 2023, driven primarily by diabetes device sales. The company has issued organic sales growth guidance between 7.5% and 8.5%.
