The Diamondback 360 Coronary Orbital Atherectomy System Receives CE Mark

The Diamondback 360 Coronary Orbital Atherectomy System has received the CE Mark and ViperWire Advance® Coronary Guide Wire with Flex Tip (ViperWire Advance with Flex Tip), reports Cardiovascular Systems.

The Diamondback 360 Coronary Orbital Atherectomy System is the market-leading coronary atherectomy device in the United States. Diamondback combines differential sanding and pulsatile forces to treat all calcium modalities, including nodular, eccentric (irregular) and concentric (ring-shaped). This device also features GlideAssist®, which allows for tracking, easier removal and smoother repositioning of the device – particularly in challenging anatomies.

Professor Michael Haude, Director of Medical Clinic, Stadtische Kliniken, Neuss, Germany, EAPCI past-president and former PCR Board member, said, “Interventional cardiologists are increasingly treating older patients with more complex coronary disease. Calcific coronary disease is more prevalent in older patients and those who are smokers, or have diabetes or renal dysfunction. We estimate 12 percent of percutaneous coronary intervention (PCI) patients present with significant calcific coronary disease. For those patients, PCI is associated with a higher risk of procedural complications, as well as poorer long-term results. As clinicians, we are eager to adopt new tools that can improve treatment and outcomes for these patients.”

Professor Nicolas Van Mieghem, Director of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands, added, “Calcific coronary artery disease creates a significant challenge to achieving the optimal stent placement needed for best PCI outcomes. By treating all types of calcium, including superficial and deep calcium, the Diamondback 360 Coronary Orbital Atherectomy System provides one unique solution to optimize stent delivery, expansion and wall apposition to safely support procedural outcomes and ensure long-term clinical results, also in highly complex anatomies. I am excited to add orbital atherectomy to the treatment options for my patients.”

Scott Ward, Chairman, President and Chief Executive Officer of CSI, concluded, “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.”

Hot this week

Avery Dennison Medical Introduces Ipdated SilFoam Lite: Sustainability, MDR Certification & Performance Improvements

The newly enhanced SilFoam Lite delivers superior efficiency and reliability, bringing improved fluid handling capabilities and improved tack. These improvements make the product ideal for customers seeking quality, high-performance solutions in wound care notes Avery Dennison Medical.

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution

Axlab, Danish Medtech Pioneer, expands to US with Advanced Robotic Tissue Sectioning for Pathology Laboratories

Kris Rokke, National Sales Director for Axlab in the US. "My team and I are extremely excited and honored about this unique opportunity to also offer this advanced technology to labs across the US and thus contribute to the pathology labs of tomorrow."

Spartan Medical Broadens Single-Use Sterile Instrument Portfolio to Improve Outcomes, Increase Efficiency, and Generate Cost Savings

Spartan Medical products portfolio of single-use, sterile med tech includes micro and minor surgical convenience kits, kerrison rongeurs, spinal and general surgical retractors, dural repair kits, synthetic biologics, and a wide range of orthopedic pre-sterilized implants and devices.