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Jun 06, 2006 (M2 PRESSWIRE via COMTEX) -- Cardima, Inc (CRDM), is a company that our research team will be tracking over the ensuing weeks. They recently came out with a significant corporate development, causing a market stir. The BWR Research Team will continue to bring its subscribers cutting edge research tools, and second to none customer service.
Cardima, Inc a developer, producer and seller of a variety of micro-catheters designed for the diagnosis and treatment of the two most common forms of cardiac arrhythmias: atrial fibrillation and ventricular tachycardia, earlier last week announced that the U.S. Food and Drug Administration has granted 510(k) marketing clearance for the new Cardima Ablation System, which ablates cardiac tissue during heart surgery using radio frequency (RF) energy.
The Cardima Ablation System uses three components: commercially available surgical radio frequency generators; the new Cardima Surgical Ablation Probe with a linear array of multi-electrodes and adjacent thermocouples using the core technology similar to the Company's REVELATION(R) series ablation micro-catheters; and a novel energy management device called the INTELLITEMP(R), which uses a temperature feedback feature to apply RF energy to single or multiple electrodes on the probe simultaneously. The new surgical ablation probe includes a specially designed stabilizer suction device with an illuminated tip for better visibility, which is clipped to the electrode array to maintain electrode-tissue contact during hands free ablation.
Cardima, Inc. developed the REVELATION Tx linear ablation micro-catheter system as a minimally invasive, single-use product designed to treat Atrial Fibrillation. Cardima submitted the Pre-Market Approval application to the FDA on September 30, 2002. On June 26, 2003, the company received a non-approval letter from the FDA, stating that the efficacy data was not sufficiently clear and supportive for the approval. On January 20, 2004, they submitted an amendment to our PMA filing, in which they provided new analysis and an expanded patient base. On May 28, 2004, Cardima received a letter from the FDA, stating that our PMA application was not approvable based on the requirements of applicable regulations. On June 10, 2005, we met with the FDA's Center for Devices and Radiological Health to continue the process towards seeking approval for the REVELATION(R) Tx ablation micro-catheter for treatment of AF.
Shares of Cardima, Inc are undergoing a bit of a sell-off as investors look for opportunities else where, however there has been no corporate developments to justify this sell-off. Currently this company is trading at $0.115, down another 13% on almost 2 million in volume. I feel that this company has some very promising potential products, however unless they are able really begin selling them, shares will continue to plummet. The last few days have been extremly difficult and i expect a positive correction in the market in the next couple of days. The Research Team will continue to follow the market sentiment on this company and numerous others
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