ROTAPRO™

Rotational Atherectomy System

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Calcium Prevalence & Rotational Atherectomy

Calcium is more common than you think. In the United States, over 30% of all patients treated for Percutaneous coronary intervention (PCI) present with some degree of calcium.

Certified operators in the US

Years of Proven Clinical Safety and Efficacy

Procedures Performed Worldwide*

* Based on Boston Scientific sales estimate.

Calcium Impacts Long-Term Outcomes

Calcium is a growing problem in the treatment of coronary artery disease. Angiographic evidence indicates a high presence of target lesion calcification in patients undergoing PCI.¹

32% moderate to severe calcium, 6% severe calcium

Pooled analysis from the HORIZONS-AMI and ACUITY Trials suggests patients with moderate/severe calcium have a significantly higher chance of death, target lesion revascularization (TLR), and major adverse cardiac events (MACE).¹

2016 data from the ARRIVE Registry also shows that moderate/severe calcium is associated with higher risk of death, target vessel revascularization, and MACE.²

Patients with calcium tend to be older with a higher prevalence of hypertension, kidney disease, previous CABG, and congestive heart failure.

Severe Calcium significantly increases the chance of death, TLR/TVR and MACE.

Data Supports Rotational Atherectomy

A 2015 large, multicenter registry evaluated the outcomes of patients undergoing rotational atherectomy (RA) in 9 major Australian hospitals over an 8-year period (16,410 non-RA PCIs, 167 RA PCIs).³

In the RA cohort:

Patients were more likely to be older with a higher prevalence of comorbidities
Patients were more likely to have complex type B2 and C lesions
37% of patients had a previously failed PCI

These patients represented the most complex of the PCI population where no other interventional therapy was an option.

Study Findings: Rotational atherectomy was safe and effective in resistant lesions

In Hospital Clinical Outcome:

No significant difference in angiographic success, dissections, perforations, or no reflow

1-Year Clinical Outcome:

No significant difference in MACE or TLR*

1 year TLR (with DES) for the RA cohort 2.9%

When lesions treated with drug eluted stents (DES) (excluding bare metal stents) were isolated, analysis of the multicenter registry revealed a TLR rate of 2.9%.

Summary

Rotational atherectomy is an important tool for treating complex lesions, with low procedural complications and MACE rates.

Despite the significantly more difficult patient population, there were no significant differences in procedural complications.

Given the excellent results, an upfront rotational atherectomy strategy for treating calcium has the potential to shorten procedure time, reduce number of overall procedures, and reduce risks to patients.

* “There was a small but significant increase in death at 12 months; however considering there was no difference in 30‑day mortality, this difference may be unrelated to RA itself and reflect the older demographic with higher prevalence of comorbidities in the cohort undergoing RA.”3

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