CRDM: Cardima Announces FDA Approval to Begin Pivotal Phase III of Clinical Trial To Treat Atrial Fibrillation and Organizational Changes
(PR Newswire, 06/22/2000 09:13)
FREMONT, Calif., June 22 /PRNewswire/ -- Cardima(R), Inc. (NASDAQ:CRDM) Cardima announced that based upon the successful results of its Phase I and Phase II study of its Revelation Tx microcatheter system, the United States Food and Drug Administration (FDA) has approved its proposal to initiate the pivotal Phase III of the Company's ongoing trial to treat paroxysmal atrial fibrillation. Up to 128 additional patients may be enrolled in the pivotal Phase III study, at 15 sites. To date 47 patients have been treated at 9 centers in Phase I and Phase II of the study.
"This is an extremely important milestone for Cardima. The Cardima Revelation Tx microcatheter is the only one in a US clinical study for approval to treat Atrial Fibrillation and it is moving into it final phase" commented Dr. Phillip Radlick, Chairman of the Board. "Recent developments in the procedure reported by Dr. Eric Chan, Vice President Product Development for Cardima, at Cardiostim show that with proper power application of RF energy the clinical outcomes can be improved as much as 200%. The results of Phase I and Phase II of the USA trial, as well as the results from European trials and continuing commercial use, indicate about 80% of the patients treated have experienced either total elimination or a significant reduction in their AF. The results to date are well within the guidelines suggested by the FDA advisory panel that would be needed for PMA approval. With more than 2,000,000 people suffering from AF in the USA alone, this disease represents one of the largest unmet clinical needs in cardiovascular medicine", Dr. Radlick added.
Cardima also announced today several organizational changes. Mr. Gabriel B. Vegh, the founder of the Company and formerly Cardima's Senior Vice President and Chief Operating Officer and a Director, was elected President and Chief Executive Officer and a Director, succeeding Dr. Phillip Radlick, who was elected Chairman of the Board of Directors.
"Over the past seven years, Gabe Vegh has led the effort to develop and market Cardima's leading edge micro catheter technology," said Dr. Radlick. "Gabe's persistent leadership, his technical expertise and in-depth understanding of the medical device markets has contributed significantly to the success of the atrial fibrillation (AF) program," he added. Of Dr. Radlick, Mr. Vegh said, "For six years, Phil's vision, energy and persistence has moved Cardima to become a leading force in the market to treat AF. His continued guidance as Chairman is most welcomed and appreciated."
Cardima also announced it had named William K. Wheeler as Senior Vice President of Sales and Marketing. Mr. Wheeler brings 20 years of experience to Cardima, most recently building a sales and distribution organization for Sulzer Vascutek in Glasgow, Scotland and prior to that, establishing and implementing global marketing and sales strategy for IMPRA, Inc. "Cardima is very fortunate to have Bill Wheeler accept the position of Senior Vice President of Sales and Marketing," stated Mr. Vegh. "His extensive experience and leadership capabilities will be valuable as we continue to expand and grow our business worldwide. With Bill's guidance, Cardima will be able to continue to exploit opportunities not only in the existing tachyarrhythmia market, but also in related fields such as venous vascular access, which Cardima has pioneered since its inception."
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitation, those set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 1999 as amended May 1, 2000 and subsequent periodic reports filed with the Securities and Exchange Commission, and the Company's ability to complete successful clinical trials, obtain timely regulatory approvals and gain acceptance from the marketplace for its products.
CONTACT: Ronald E. Bourquin, Vice President and Chief Financial Officer of Cardima, Inc., 510-354-0162. SOURCE Cardima, Inc. |
