Medtronic Announces CE Mark for New Lower Profile Hawkone 6F Directional Atherectomy System
January 24, 2017 at 04:00 am
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Medtronic plc announced CE (Conformite Europeene) Mark approval for the HawkOne(TM) directional atherectomy system in a lower profile size for treating patients with peripheral artery disease (PAD). The new HawkOne 6 French (6F) provides an effective and easy-to-use treatment option for patients with PAD both above and below the knee with a single device. The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. PAD is a serious, chronic condition that affects more than 200 million people worldwide.1 In PAD, arteries in the legs become narrowed or blocked by plaque. This narrowing of the blood vessel reduces blood flow to the leg, which can result in severe pain and limit physical mobility. Blocked arteries below the knee are more likely to be calcified, linked to lower treatment success,2 and may also develop into critical limb ischemia (CLI), which can result in non-healing leg ulcers and increased risk of amputation.3, 4 The HawkOne system also enables physicians to treat severe calcified lesions more efficiently with no increase in cut depth. The system can treat calcified lesions up to two times more effectively than the TurboHawk(TM) device.5 The HawkOne system has a preloaded flush tool, which improves cleaning time by up to 55% when compared to the TurboHawk high efficiency cutter.6 The 6F size is designed to simplify device selection and provide easy set-up with no capital equipment. In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).
MEDTRONIC PLC 
