Diamondback 360 Coronary Orbital Atherectomy System Large Study Demonstrates Exceptional Safety and High Procedural Success: Reported at TCT Connect 2020

Monday, October 26, 2020

October 14, 2020

Diamondback 360 Coronary Orbital Atherectomy System large retrospective observational study was released at TCT Connect 2020. The news was announced today by Cardiovascular Systems.

The presentation, authored by Nirat Beohar, MD, Professor of Medicine and Vice Chief, Columbia University Division of Cardiology at the Mount Sinai Medical Center, Miami, Fla., et al1, shows exceptional safety and high procedural success in 519 patients with severely calcified cardiac disease who were treated with orbital atherectomy prior to stent deployment.

Said Beohar, “We studied over 500 patients with challenging coronary lesions. The lesions were heavily stenosed and calcified, measuring up to 60 mm in length. Over half were classified as ACC/AHA Type C lesions, the most difficult anatomy. Despite treating these most complex cases, procedural and component angiographic complication rates were all below 1% and stents were successfully deployed in all procedures. In this contemporary real-world experience, OAS was found to be safe; successfully streamlining treatment for patients with the most significant coronary disease.”

Orbital Atherectomy System for Treating De Novo, Severely Calcified Coronary Lesions: A Tertiary Center Experience

Patients

519

Percent Stenosed

86.8%

Type C Lesions

53.5%

Average Lesion Length

22.6 mm

Angiographic Complications:

Dissection

0.4%

Perforation

0.8%

Slow/No Re-flow

0.0%

Lesion Cross Rate

100.0%

Stent Delivery and Deployment

100.0%

Average Fluoroscopy Time

19.6 min.

30-Day MACE2

1.3%

30-Day Cardiac Death

0.8%

30-Day MI

0.8%

Severe calcification of coronary lesions represents a major challenge to minimize procedural complications and optimize stent delivery, expansion and apposition for best PCI outcomes. The Diamondback 360® Coronary OAS uses a powerful dual mechanism of action to treat both superficial and deep calcium.

Diamondback 360 Coronary Orbital Atherectomy System study, Scott Ward, Chairman, President and Chief Executive Officer, said, “This study expands our evidence demonstrating the safe, effective use of orbital atherectomy to treat a real-world complex patient population. With 11 studies tracking over 2200 patients to date, CSI continues to extend its leadership in the development of medical evidence for the treatment of patients with severe coronary artery disease.”


References

1 Orbital Atherectomy System for Treating De Novo, Severely Calcified Coronary Lesions: A Tertiary Center Experience. Authors Nirat Beohar, MD, Juan M. Vinardell, MD, Carlos Podesta, MD, Nafees Mohammed, MD, Todd Heimowitz, DO, Christian Koelbl, MD, PhD, Helen Parise, PhD, and Ajay Kirtane, MD SM.

2 MACE is defined as the composite of Cardian Death, MI, ischemic CVA and hemorrhagic CVA.

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