Johnson & Johnson initiates intravascular lensStudy in hard-to-reach coronary arteries
In the ever-evolving world of medical technology, Shockwave Medical has made significant strides with its Javelin intravascular lithotripsy (IVL) catheter. This innovative device, which was unveiled at an investor event in October 2023, is set to revolutionise the treatment of difficult-to-cross arterial lesions, particularly in coronary and peripheral vessels.
The Javelin IVL catheter, manufactured by J&J's Shockwave Medical, stands out from other Shockwave products and rival catheters from Abbott and Boston Scientific. Unlike its counterparts that send waves from a balloon catheter, the Javelin device emits waves from its tip, addressing a key challenge when balloons are too bulky to cross tight lesions.
Shockwave developed the Javelin device to address the issue that balloon-based catheters are unable to pass through some vessels, preventing the use of Shockwave's other IVL devices to remove calcium deposits. The company believes that the Javelin IVL catheter could potentially address up to 5% of the market at most.
Johnson & Johnson announced on Monday that they have enrolled the first patient in a pivotal study for the device, designed to clear difficult-to-cross coronary arteries. Meanwhile, the Food and Drug Administration cleared a Javelin device for use in peripheral vessels last year.
The latest generation of the Javelin IVL catheter, known as the C2 Aero catheter, improves deliverability, enabling physicians to cross previously uncrossable calcific narrowings more effectively. This enhancement makes the Javelin system Shockwave’s second IVL platform.
Shockwave is also progressing clinical research with the Javelin coronary IVL catheter, undertaking studies like the Forward CAD trial aimed at U.S. FDA approval, as well as early feasibility studies in the UK. The new study will enroll up to 158 patients across around 35 sites in the U.S. and U.K. to generate data to unlock more of the coronary market.
The Javelin IVL catheter's unique design sets it apart in the market. Compared to other products on the market, such as earlier balloon-based IVL catheters or other modalities that mechanically disrupt calcium, the Javelin IVL catheter offers enhanced crossing ability due to its catheter design. This positions it uniquely for treating severe calcific disease both in peripheral and coronary arteries.
The market for balloon-free devices, such as the Javelin IVL catheter, may be relatively small. However, the significant investment in R&D by Johnson & Johnson-backed Shockwave Medical, driven by physician feedback and clinical need, suggests ongoing enhancements in device iterations and indications.
In a separate development, Boston Scientific paid $443 million upfront for Bolt Medical, a company working on a balloon catheter before its acquisition. Abbott, on the other hand, acquired an IVL program as part of its $890 million takeover of Cardiovascular Systems. Abbott's device uses a balloon to widen parts of the arteries that are narrowed by calcium, while Abbott's IVL device uses a balloon catheter to deliver sonic pressure waves that fracture calcium within the vessel wall.
Journalists Susan Kelly and Ricky Zipp have reported on these acquisitions and developments by Boston Scientific, Abbott, and J&J. The market for medical technology continues to evolve, with companies like Shockwave Medical pushing the boundaries of innovation to provide better treatment options for patients with challenging calcific arterial lesions.
[1] Shockwave Medical. (2023). Press Release: Shockwave Medical Announces First Patient Enrolled in Pivotal Study for Javelin Coronary IVL Catheter. Retrieved from https://www.shockwave-medical.com/news/press-releases/detail/115/shockwave-medical-announces-first-patient-enrolled-in [2] Shockwave Medical. (2022). Press Release: Shockwave Medical Announces First Patient Treated with Javelin Coronary IVL Catheter in Early Feasibility Study in the UK. Retrieved from https://www.shockwave-medical.com/news/press-releases/detail/107/shockwave-medical-announces-first-patient-treated-with [3] Shockwave Medical. (2023). Press Release: Shockwave Medical Announces Completion of Enrollment in the Forward CAD Trial. Retrieved from https://www.shockwave-medical.com/news/press-releases/detail/116/shockwave-medical-announces-completion-of-enrollment-in-the-forward-cad-trial
- Shockwave Medical's Javelin IVL catheter, a game-changer in medical technology, has the potential to revolutionize Treatment of difficult-to-cross arterial lesions, particularly in coronary and peripheral vessels.
- Different from other Shockwave products and rival catheters from Abbott and Boston Scientific, the Javelin device emits waves from its tip, making it more effective when balloons are too bulky to cross tight lesions.
- The Food and Drug Administration cleared a Javelin device for use in peripheral vessels last year, while Johnson & Johnson is currently conducting a pivotal study for the device in coronary arteries.
- The latest version of the Javelin IVL catheter, the C2 Aero catheter, has improved deliverability, enabling physicians to cross previously uncrossable calcific narrowings more effectively.
- Shockwave Medical is also involved in clinical research, such as the Forward CAD trial aimed at U.S. FDA approval for the Javelin coronary IVL catheter.
- Compared to other balloon-based IVL catheters or other modalities, the Javelin IVL catheter's unique design offers enhanced crossing ability due to its catheter design, making it especially suitable for treating severe calcific disease both in peripheral and coronary arteries.
- While the market for balloon-free devices may be small, the significant investment by Johnson & Johnson-backed Shockwave Medical suggests ongoing improvements in device iterations and indications, driving the evolution of the medical technology market.
