FDA Dispute Resolution Panel Recommends to Not Approve Cardima, Inc.'s REVELATION(R) Tx Microcatheter System
The REVELATION® Tx system is a minimally invasive, single-use, microcatheter-based product designed to provide easy access to arrhythmia-causing tissue, creating linear lesions or restricted pathways, and restoring normal sinus rhythm to the heart using radiofrequency (RF) energy.
Gabe Vegh, Chief Executive Officer of Cardima, said, "I am disappointed that the Panel voted against the approval of the REVELATION® Tx. Cardima will consider its options regarding this decision in the US. The Company will continue to market its next generation ablation EP systems, which include the REVELATION® T-Flex and the INTELLITEMP®, in the European Union and the rest of the world where it is licensed to promote and sell these products. Also Cardima will continue to search for marketing partners for its US-approved Surgical Ablation System (SAS) and in the markets outside of the US where it is licensed to promote and sell the product. In addition, the Company will continue to promote its Diagnostic System which is approved in the US and the rest of the world."
About Cardima
Cardima, Inc. has developed the REVELATION® Tx, REVELATION® T-Flex and REVELATION® Helix linear ablation microcatheters, the NAVIPORT® deflectable guiding catheters, and the INTELLITEMP® energy management system for the minimally invasive treatment of atrial fibrillation. The REVELATION® Tx, REVELATION® T-Flex and REVELATION® Helix systems and the INTELLITEMP® have received CE Mark approval in Europe. The Company has also developed and obtained marketing clearance in the USA for a Surgical Ablation System, which is used by cardiac surgeons to ablate cardiac tissue during heart surgery using radio frequency (RF) energy. For more information please visit the Company's website at http://www.cardima.com.
Forward-Looking Statements
The statements in this press release that are not descriptions of historical facts are forward-looking statements that are subject to risks and uncertainties. These include statements included in this press release related to Cardima's amendment to its PMA for treating symptoms of atrial fibrillation including the expected time period for the FDA's review of that amendment and the possibility of receiving approval for the treatment, all of which are prospective. Such statements are only predictions and reflect the Company's expectations and assumptions as of the date of this press release based on currently available operating, financial, and competitive information. The actual events or results may differ materially from those projected in such forward-looking statements due to a number of factors, including risks involved with Cardima's ability to obtain regulatory approval in the United States for its Ablation System for use in treating the symptoms of atrial fibrillation within its anticipated timeframes, if at all; risks associated with the Company's ability to successfully commercialize its Cardiac Ablation System in the United States and elsewhere if its Cardiac Ablation System is approved for use in the United States; risks associated with the Company's dependence on patents and proprietary rights; risks associated with the Company's protection and enforcement of its patents and proprietary rights; risks associated with the development or availability of competitive products or technologies; and the other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. The Company expressly disclaims any intent or obligation to update any of these forward-looking statements.
Contact: Contact: Cardima, Inc. Gabriel Vegh 510-354-0300 http://www.Cardima.com
Source: Cardima, Inc.