In the aftermath of the procedure, Dr. Loulmet, who also heads up the Atrial Fibrillation Programme for Lenox Hospital, commented: "The unique technology behind the Cardima Ablation System proved to be a critical and powerful tool for this especially difficult case. The ease of use, the power, and the depth of penetration given the small size of the catheter is impressive."
"We are pleased that physicians at such an esteemed medical institution as Lenox Hill Hospital have opted to be the first to use our system", stated Gabriel Vegh, Chief Executive Officer of Cardima. "This new tool to create long, linear lesions that substantially replicate those of the highly successful surgical Maze procedure, is a ground-breaking addition to the treatment of AF."
Cardima's Ablation System received 510(K) approval by the United States Food and Drug Administration (FDA) on February 4, 2003, to ablate cardiac tissue during heart surgery via the use of radio frequency (RF) energy. This system is expected to be used primarily by cardiac surgeons in the treatment of AF. The physicians performing the procedure described above have been engaged by Cardima as consultants and one or more of them hold equity interests in the company.
The Cardima Ablation System uses commercially available surgical radio frequency generators, a Cardima surgical probe with multi-electrode linear array micro-catheter technology similar to the company's REVELATION Tx, a deflectable guiding sheath similar to the NAVIPORT guiding catheter, and a novel power-channeling device developed by Cardima, the INTELLITEMP, which allows RF energy to be applied to any single, any multiple, or all electrodes on the probe, simultaneously.
The surgical ablation probe is also deflectable, allowing surgeons the flexibility to create lesions in various shapes as needed to complete the procedure effectively. The company believes that the Cardima Ablation System can significantly reduce the time required to form lesions and can sense tissue temperature interactively to ensure lesions are uniform, thin and linear. This system is part of Cardima's AF strategy, which is to develop tools to treat patients suffering from irregular heart rhythms.
Cardima Inc. has developed the REVELATION Tx, REVELATION T-Flex and REVELATION Helix linear ablation micro-catheter systems for the minimally invasive treatment of atrial fibrillation. The REVELATION Helix was developed for the treatment of AF originating in the pulmonary veins of the heart. The REVELATION Tx, REVELATION T-Flex and REVELATION Helix systems have received CE Mark approval in Europe.
The company has also developed a Surgical Ablation System, which is expected to be used by cardiac surgeons for the treatment of AF, to ablate cardiac tissue during heart surgery using radio frequency (RF) energy. In February 2003, the company announced that it had received FDA 510(k) clearance to market the Surgical Ablation System in the United States.