Peripheral Artery Disease
Shockwave Medical’s initial focus of treatment is Peripheral Artery Disease, which affects more than a quarter of a billion people worldwide.2 Calcium is one of the most widely encountered predictors of both acute and long-term failures.3 Shockwave Medical’s Intravascular Lithotripsy (IVL) Technology was designed to disrupt calcified plaque in peripheral vasculature, while minimizing injury to soft tissue. IVL Technology is built on a familiar balloon catheter platform, so that even historically challenging Peripheral Artery Disease patients can be treated effectively with little alteration to existing angioplasty technique or procedure flow.1
Coronary Artery Disease
Shockwave Medical has recently expanded its focus to include development of devices for the treatment of Coronary Artery Disease (CAD). In CAD, the presence of calcium frequently results in suboptimal stent expansion and clinically significant stent malapposition leading to increased risk of restenosis and thrombosis.4 Much like in the treatment of PAD, IVL Devices designed for use in coronary vessels will also combine lithotripsy technology with a traditional balloon catheter in a single device. Shockwave Medical has completed feasibility studies of OTW and RX Intravascular Lithotripsy (IVL) Technology for use in coronary artery disease. The RX system is currently under further clinical evaluation.
Heart Valve Disease
Calcific Heart Valve Disease is a disorder that spans the range from a mild thickening known as sclerosis to an obstructive calcification known as stenosis.5 Mild sclerosis can, and typically does, progress to valve stenosis over time.
Shockwave Medical is developing and evaluating a new application of Intravascular Lithotripsy (IVL) Technology designed to disrupt calcifications on the leaflets of the aortic valve.
Shockwave Medical has completed a feasibility study for the treatment of aortic stenosis.
- Levin S. “Shockwave Medical: Cracking the Calcium Code in Cardiology.” The MedTech Strategist, 2015 Aug 12; 12(2):30-37.
- Kaiser C. “PAD Incidence Rising Sharply Worldwide.” MedPage Today, http://www.medpagetoday.com/Cardiology/PeripheralArteryDisease/40803.
- F.Fanelli et al.: Calcium Assessment and Impact on DEB. Cardiovasc Intervent Radiol (2014) 37:898-907
- M. Madhavan et al.: Coronary Artery Calcification. JACC (2014). May 6, 2014:1703–14