Tele: 561.316.3330
Breaking Medical Device News

Monday, September 27, 2021
HomeClinical Trials, Studies, Data UpdatesCardiovascular Systems Reports: New Study Demonstrates Exceptional Performance With Diamondback 360® Coronary Orbital Atherectomy System (OAS) Dual Mode of Action

Cardiovascular Systems Reports: New Study Demonstrates Exceptional Performance With Diamondback 360® Coronary Orbital Atherectomy System (OAS) Dual Mode of Action

Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that results from a real-world optical coherence tomography (OCT) imaging study of coronary OAS patients were released at EuroPCR 2021.

The study conducted by Surendra Avula, MD, et al, at the University of Illinois, Chicago, was designed to assess the dual mechanism of action of orbital atherectomy. Twenty consecutive patients with severely calcified lesions identified by coronary angiography were enrolled and treated by a single operator. All patients received a prespecified treatment algorithm including at least three runs of orbital atherectomy at low speed with OCT imaging pre- and post-OAS prior to stenting.

There were no angiographic complications in any patients, including 0% dissection, 0% perforation and 0% slow flow/no reflow. Using OCT assessment post-atherectomy, 100% of treated lesions showed calcium fracture (defined as fissures, craters and/or smooth concave ablation) effecting both superficial and deep calcium. Stent delivery and subsequent stent expansion was subsequently achieved in all patients (100%).1

Said Avula, “Orbital atherectomy is used to facilitate stent expansion in severely calcified lesions. In this small observational study we utilized OCT to demonstrate the dual mechanism of action of orbital atherectomy. We clearly observed sanding of intima and fractures of both superficial and deep calcium in the coronary tree. This strategy of peri-procedural OCT imaging in combination with lower speed orbital atherectomy is a paradigm shift in the effective treatment of the calcified coronary tree, and represents a new standard for patient outcomes and safety.”

Severe calcification in coronary lesions impedes optimal stent delivery, expansion and apposition and leads to increased procedural complications and overall inferior results. The Diamondback 360® Coronary OAS uses a powerful dual mechanism of action to treat both superficial and deep calcium, thus restoring native vessel compliance, simplifying procedural workflow, and enhancing PCI outcomes.

Cardiovascular Systems President and Chief Executive Officer Scott Ward said, “This study highlights the benefits of imaging to optimize vessel preparation and reinforces the efficacy of orbital atherectomy’s unique mechanism of action which both ablates and fractures calcium.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

ProSomnus® Sleep Technologies Adds John E. Remmers, MD, to Leadership Team

Dr. John E. Remmers will provide expert medical and strategic guidance on a range of initiatives, including research and development, regulatory clearances, company strategy, medical education, and clinical investigations.

Nanox to Announce Zebra Medical Vision Secures 8th 510K FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health Offering

On August 10th, 2021 Nanox announced that it had entered into an acquisition agreement via merger with Zebra Medical Vision LTD.

Christopher Joyce Joins Miach Orthopaedics as VP & CFO

Christopher Joyce has joined as vice president and chief financial officer, and Kevin Sidow has been appointed to the company’s board of directors.

NGMedical GmbH Receives FDA Clearance for Its AM Titanium Lumbar Interbody BEE® PLIF

The BEE® PLIF cage has been created to benefit from additive manufacturing features. The purposefully designed honeycomb endplate design reduces the risk of subsidence, while allowing fusion.

Recombinant Technologies is Raising Capital to Roll Out a Game Changing Alzheimer’s Treatment

Recombinant Technologies is focused on treating the root cause of Alzheimer's Disease delivering a huge improvement in the quality of life of those afflicted.

Tyber Medical Reaches Agreement to Acquire CatapultMD

Once the acquisition is complete, Tyber Medical will own and operate a combined 100,000-square feet of manufacturing space between its Pennsylvania headquarters and Florida-based facilities.

Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System

The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.

Matthew Cranfill New ExtriCARE USA Director Of Clinical Services

"Matt's impressive experience and skillset easily made him our top pick," said Peter Mason, President of ExtriCARE USA.

By using this website you agree to accept Medical Device News Magazine Privacy Policy