Didier F. Loulmet, M.D., Chief of the Minimally Invasive Robotic Cardiac Surgery Programme, and head of the Atrial Fibrillation Programme for Lenox Hospital, began using the Cardima SAS last year during "open chest" procedures to treat chronic AF in patients who required direct valve repairs. An open chest procedure involves cutting through the sternum where the rib cage comes together in the middle of the chest. This allows the surgeon to "open" the chest to have direct visual access to the heart. The opening is about 4 to 6 inches long and about 4 to 5 inches wide.
A "less invasive" procedure gains access to the heart by making a much smaller cut between the ribs, which creates an opening about 2 inches long and only 3/4 to 1 inch wide. This is called a mini thoracotomy and typically allows faster recovery because it does not involve healing of bone. Less invasive procedures such as a mini thoracotomy are limited to the use of small profile devices such as the Cardima SAS. Dr. Loulmet recently applied the Cardima Surgical Ablation technology in two AF cases during a mini thoracotomy, or "less invasive" approach.
Dr. Loulmet commented: "The unique technology behind the Cardima Ablation System proved to be a critical and powerful tool for this less invasive approach. The ease of use, power, and depth of penetration is impressive. Because Cardima's SAS is flexible and has a very low profile, it allows multiple opportunities to access the heart to treat AF. This unique versatility gives us the ability to use this technology on both the open and the less invasive procedures. This is a plus when addressing the needs of cardiac surgeons faced with the treatment of atrial fibrillation."
"We are pleased to learn that Cardima SAS technology performed well during this less invasive surgical approach", stated Gabriel Vegh, Chief Executive Officer of Cardima. "This minimally invasive approach marks an important milestone in the future treatment of AF, opening the door to the prospect of our technology being broadly used in a stand alone procedure to treat all patients affected by atrial fibrillation."
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.
The Cardima Ablation System uses commercially available surgical radio frequency generators, a Cardima Surgical Probe with multi-electrode linear array microcatheter technology similar to the Company's REVELATION Tx, 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 microcatheters, the NAVIPORT deflectable guiding catheters, and the INTELLITEMP energy management system for the minimally invasive treatment of atrial fibrillation (AF). 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 and the INTELLITEMP 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 to treat AF by ablating cardiac tissue during heart surgery using radio frequency (RF) energy. In February 2003, the company had received FDA 510(k) clearance to market the Surgical Ablation System in the United States. More company news is available in the VMW October 2003 article Cardima's Surgical Ablation System breakthrough for patients with heart disease.