Medical device company Cardiovascular Systems (CSI) has secured CE mark approval for its Diamondback 360 coronary orbital atherectomy system (OAS) and ViperWire Advance coronary guide wire with flex tip (ViperWire Advance with flex tip).
To treat all calcium modalities, including nodular, eccentric (irregular) and concentric (ring-shaped), Diamondback integrates differential sanding and pulsatile forces.
The system is also provided with GlideAssist that facilitates tracking, easier removal and smoother repositioning of the device, specifically in challenging anatomies.
According to the company, Diamondback 360 Coronary OAS showed durable results with low target lesion revascularization (TLR) rate of 3.4% in drug eluting stent (DES) subset at one year in the ORBIT II pivotal trial.
The percutaneous orbital atherectomy system is indicated to support stent delivery in patients with coronary artery disease (CAD) who are suitable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions, the firm said.
CSI president and CEO Scott Ward said: “Europe represents a large, underpenetrated market where coronary atherectomy is currently underutilized for the treatment of complex cardiovascular disease.
“We look forward to collaborating with European physicians to expand the treatment options for patients with severely calcified coronary artery disease.”
Based in Saint Paul of Minnesota, CSI is engaged in the development and commercialisation of advanced solutions to treat vascular and coronary disease.
The firm’s orbital atherectomy system is developed for the treatment of calcified and fibrotic plaque in arterial vessels throughout the leg and heart.
In addition, it is also designed to address multiple limitations associated with existing surgical, catheter and pharmacological treatment alternatives.
In August 2019, CSI purchased the Wirion embolic protection system and related assets from Gardia Medical for an undisclosed sum.
Wirion secured CE mark approval in June 2015 and clearance from the US Food and Drug Administration (FDA) in March 2018.
It is a distal embolic protection filter designed to capture debris, which can be associated with all types of peripheral vascular intervention (PVI) procedures.
