SAN DIEGO, Feb. 2 /PRNewswire/ -- MedWaves, Inc. announces the receipt of Medical Device Directive (MDD) CE Mark Certification. This is in addition to having already received U.S. FDA 510(k) clearance to market the Company's patented Microwave Coagulation/Ablation System for surgical applications. The system and single patient use devices enable surgeons and interventional radiologists to treat soft tissue problems, such as tumors, using microwave thermal ablation. The clearance sets the stage for rapid expansion of the Company's product portfolio and indications for use through additional U.S. FDA clearances. The Company's proprietary technology focuses on the development of minimally invasive devices in wide ranges of size, shape and flexibility intended to meet clinicians' requirements for treatment of tumors in bone, liver, lung and other locations.
MedWaves Microwave Coagulation/Ablation System overcomes limitations of existing microwave and radiofrequency (RF) thermal ablation technologies, the standard of treatment for cancerous tumor patients who are not candidates for resection surgery. For these patients, microwave ablation can be adjunctive or a replacement for the curative and/or palliative therapies of standard therapies, such as chemotherapy and/or radiation. It can be an option for patients where other thermal modalities are not possible due to tumor size, location or patient condition.
About the AveCure® Ablation System and Devices:
-- FDA 510(k) clearances received for microwave coagulation/ablation system, which includes: Microwave power generator/controller, 14, 11 and 9 gauge probes
-- CE Mark certification received for microwave coagulation system, which includes: Microwave power generator/controller, 16, 14, 11 and 9 gauge probes
-- Only approved ablation system that provides physicians real-time temperature feedback and control
-- Proprietary efficient dynamic power delivery is capable of producing larger ablation zones relative to existing energy-based modalities
-- Pre-clinical results suggest ablation zone correlation to CT and ultrasound images
-- Disposable, single-use delivery devices provide valuable recurring revenue stream
-- Elegant single generator and single device design (cost savings and attractive improvement over marketed multi-generator, multi-device offerings)
-- Turnkey device platform presently poised for commercial launch
About MedWaves, Inc.
MedWaves, Inc. develops innovative and proprietary microwave ablation technology for the minimally invasive coagulation/ablation of soft tissues and tumors. The Company's management team has extensive experience in the medical device marketplace. MedWaves' clinical advisory board membership includes renowned surgeons from UCSD, City of Hope and The Cushier Skills Center. MedWaves, Inc. is located in San Diego, California, USA.
Ted Ormsby, President/CEO
16760 W Bernardo Drive
San Diego, CA 92127
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