Coronary Portfolio of Solutions

The ORBIT II pivotal trial was a prospective, multi-center study conducted in the U.S. that evaluated patients with severely calcified coronary lesions treated with Diamondback 360® Coronary Orbital Atherectomy System (OAS) Classic Crown prior to stent implantation. Key Takeaways ORBIT II demonstrated long term durable results with a low target lesion revascularization (TLR) rate of 3.4% at 1 year in the drug-eluting stent (DES) subset (N=389/443) ORBIT II met the primary safety and efficacy endpoints by a significant margin Study Design 443 patients with severely calcified lesions were enrolled at 49 U.S. Sites Designed to evaluate the safety and efficacy of the Diamondback 360 Coronary OAS Classic Crown Primary Safety Endpoint: Major adverse cardiac events (MACE) at 30 days Primary Efficacy Endpoint: Procedural Success defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE

COAST was a prospective, multi-center study conducted in the U.S. and Japan that evaluated patients with severely calcified coronary lesions treated with the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Micro Crown prior to stent implantation. Key Takeaways COAST patients had a low rate of target lesion revascularization (TLR) of 6.3% at one year COAST trial showed that the Diamondback 360® Coronary OAS Micro Crown was safe and effective in treating severely calcified lesions Study Design 100 patients with severely calcified lesions were enrolled at 12 sites in U.S. and 5 in Japan Designed to evaluate the safety and efficacy of the Diamondback 360® Coronary OAS Micro Crown Primary Safety Endpoint: Major Adverse Cardiac Events (MACE) at 30 days Primary Efficacy Endpoint: Procedural Success defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE

ECLIPSE: Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug Eluting StEnts   Purpose of the ECLIPSE Trial Severely calcified coronary lesions represent 6-20%1,2 of the total Percutaneous Coronary Interventions (PCI) market (880K annual procedures). Coronary atherectomy represents < 5%3,4 of the PCI market and is not currently classified as the Standard of Care (SOC) in treatment guidelines. ECLIPSE is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Classic Crown compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions. References: 1. Genereux P, et al. J Am Coll Cardiol. 2014; 63(18): 1845 - 1854. 2. Bourantas CV, et al Heart. 2014; 100(15): 1158-1164. 3. El Hajj M, et al. Cath Lab Digest. 2018;26(6):June 2018. 4. Arora S, et al. Am J Cardiol. 2016;117(4):555-562.   Study Design Approximately 2,000 patients with severely calcified coronary lesions will be enrolled at approximately 150 sites in the U.S. The imaging cohort will consist of approximately 250 subjects per arm with an optical coherence tomography (OCT) assessment of acute minimum stent area (MSA) at the conclusion of the procedure. Co-Primary Endpoints: Acute MSA defined as in-stent minimal cross-sectional area as assessed by OCT at the conclusion of the procedure in the OCT imaging cohort. 1-year target vessel failure (TVF) defined as the composite of cardiac death, target vessel related myocardial infarction, or ischemia-driven target vessel revascularization. Secondary Endpoints: Procedural Success defined as successful stent delivery with final Core Lab defined TIMI flow 3 and angiographic in-stent diameter stenosis [DS] ≤ 20%, and with the absence of any of the following: stent loss, coronary perforation, or intra-procedural death. Strategy success defined by Procedural Success without crossover to alternative treatment.