Atherosclerosis is the Build-Up of Fatty or Calcified Plaque in the Arteries that can Block or Disrupt Blood Flow
Coronary artery disease (atherosclerosis in the arteries that provide blood flow to the heart) can cause adverse symptoms and heart attacks and is the leading cause of death in the US and worldwide. 1, 2
Over 4 million interventional (percutaneous) coronary procedures are performed annually worldwide to address artery disease and the narrowing of arteries. All interventional coronary procedures worldwide currently involve balloon angioplasty, with over 85% also involving stent implant and nearly 67% involving drug-eluting stent implant.3 Nearly 2 million additional balloon angioplasty procedures are performed annually to treat peripheral artery disease (outside the heart).4 Approximately 8.5 million people in the United States have peripheral artery disease, including up to 20% of individuals older than age 60, according to the CDC.
Although great medical advancements have been made to address coronary artery disease, limited approved treatments exist for in-stent restenosis (ISR), small vessels (<2.75 mm), bifurcation lesions, bare metal stent (BMS) patients who are not candidates for dual-antiplatelet therapy (DAPT) and below-the-knee (BTK) lesions.
Orchestra BioMed™’s Virtue® Sirolimus-Eluting Balloon (SEB) aims to be the first approved drug-eluting balloon technology for coronary artery use in the US, with an initial market opportunity in coronary ISR.
1 American Heart Association, Heart Disease and Stroke Statistics 2017, At-a-Glance.
2 World Health Organization, “The Top 10 Causes of Death,” Fact Sheet, Updated January 2017.
3 MedMarket Diligence, LLC, “The Evolution of Coronary Revascularization Markets”, November 2, 2016.
4 MedMarket Diligence, LLC, “The global dynamics of cardiovascular surgical and interventional procedures”, April 5, 2017.