FDA Grants Clearance to MedWaves for Microwave Coagulation/Ablation System

 

April 9, 2008

MedWaves Inc. received FDA 510(k) clearance in January 2008 for 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 FDA 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.

The company said the 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 company says 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 (more than 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

According to the company, the MedWaves Microwave Coagulation/Ablation System Unique is also unique to other microwave coagulation/ablation systems because it provides:

- 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 probe design provides thermal monitoring that is highly correlated with tissue temperature with minimal temperature offset

- The company's probe designs can coagulate/ablate the same volume of tissue using 50 to 70 percent less power than other microwave systems

January 2008

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