Healthcare Industry News: Medwave
News Release - January 31, 2008
MedWaves, Inc. Announces Receipt of United States Food and Drug Administration 510k Clearance to Market Its Patented Microwave Coagulation/Ablation System
SAN DIEGO, Jan. 31 (HSMN NewsFeed) -- Medwaves, Inc. announces the receipt of USFDA 510k clearance to market its patented Microwave Coagulation/Ablation System for general surgery use for the coagulation and ablation of soft tissues. The system is comprised of a microwave generator and single patient use sterile devices. The clearance sets the stage for rapid expansion of a product portfolio and indications for use through additional USFDA submissions and clearances. The Company's proprietary technology allows for the development of minimally invasive devices in wide range of sizes, shapes and flexibility to meet clinicians' requirements in bone, liver, lung and other tumors.About The Avecure(TM) Ablation System
Medwaves Microwave Coagulation/Ablation System overcomes limitations of existing microwave and radiofrequency (RF) thermal ablation technologies, the standard of treatment for oncology patients who are not candidates for surgery. Initially the Company focused on the general use of its coagulative technology with a high percentage of the anticipated use in patients with bone, liver and lung tumors. For these patients, adjunctive use of microwave ablation can assist in the curative and/or palliative goals of standard therapies e.g. chemotherapy and/or radiation. It can be an option for patients where other thermal modalities are not possible due to tumor size or location. The system offers potential advantages over RF thermal ablation methods in the following ways:
-- Consistency and predictability of lesion creation
-- Ability to treat large lesions (over 3 cm)
-- Increased safety due to the elimination of grounding pads and the
resultant skin burns due to poor contact
-- More even distribution of the thermal energy delivery in the tissues
that is not dependent upon low impedance paths that can be
unpredictable
-- Microwave energy delivery is not affected by high impedance (less
conductive) tissues providing another option for thermal therapy
-- Range of probe designs for maximum flexibility to match tumor
geometries
Unique to other microwave coagulation/ablation systems the Medwaves Microwave Coagulation/Ablation System provides potential advantages in the following ways:
-- Provides clinicians with an automatic temperature regulated
coagulation/ablation process that allows the clinician to control
precisely the tissue temperature generated throughout the
coagulation/ablation process
-- The Company's proprietary probe design provides thermal monitoring that
is highly correlated with tissue temperature with minimal temperature
offset
-- The Company's proprietary probe designs can coagulate/ablate the same
volume of tissue using 50% to 70% less power than other microwave
systems
About Medwaves, Inc.
Medwaves, Inc. develops novel 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.
Source: MedWaves
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