Today announced commercial introduction in Europe of an innovative pen-like device designed to help surgeons quickly treat one of the world’s most difficult cardiac arrhythmias at the same time they operate to replace a heart valve or perform a coronary artery bypass procedure.
The Medtronic CardioblateÔ Surgical Ablation Pen, awarded the CE (Conformitè Europeeńe) Mark on March 13, 2001, is a hand-held, single-use, irrigated radiofrequency ablation instrument used to create spot or linear lesions in the heart’s upper chambers to block the errant electrical signals that cause atrial fibrillation. Because it allows the surgeon to “draw” lines that then form scar tissue – rather than the cutting and sewing of incisions used in the complex “Maze” operation – the Cardioblate pen significantly reduces the critical “cross-clamp” time required to complete the procedure.
Atrial fibrillation is estimated to affect more than 5.5 million worldwide. Prevalence of the disease increases with age, doubling in each decade of age after 50. More than a third of those affected are considered to have “chronic” atrial fibrillation, where treatments, such as drugs and electrical cardioversion, have failed. Studies have shown that frequent or long-term episodes of atrial fibrillation can cause changes in the heart’s electrical system, making AF episodes more frequent and more resistant to treatment. The “Maze” operation is the only treatment found to be successful in treating chronic atrial fibrillation, but it has not been widely adopted by surgeons because of its complexity and length. The prospect of a simple irrigated radiofrequency ablation treatment, such as that provided by the Cardioblate pen, signals a possible cure for the condition and an attractive option for cardiac surgeons who are already performing a surgical procedure for another problem, such as valve repair or replacement.
The Cardioblate pen, powered by an external generator, uses saline solution from an infusion pump to irrigate the lesion point, providing a low impedance path for radiofrequency energy. This irrigation feature also is designed to cool outer tissue to allow deeper heat penetration, which is necessary to ensure a complete electrical block. The insulated shaft of the device is malleable, allowing the surgeon to shape it to create lesions in all the necessary areas of the left and right atria.
Krishna Khargi, M.D., of the Department of Cardiothoracic Surgery at the University Hospital in Bochum Germany, was the first to use the Cardioblate pen. He states, “Our own data indicates that the irrigated, cooled-tip radiofrequency ablation device appears to be effective in producing linear intra-atrial ablation lesions. If this observation proves to be correct, the threshold for the surgical treatment of chronic atrial fibrillation will be lowered substantially.” Bochum is one of several European and U.S. medical centers that will gather data on the use of the device for presentation to the U.S. Food and Drug Administration to support Medtronic’s application to market the ablation pen in the United States. “The Cardioblate product marks the first in a series of new, innovative and minimally invasive solutions from Medtronic that will continue to transform the way cardiac surgery is performed,” said Bob Guezuraga, president of Medtronic Cardiac Surgery.
Several Medtronic implantable devices, along with electrophysiological ablation catheters manipulated from outside the body, have been designed to identify and treat atrial fibrillation. The Cardioblate pen provides Medtronic with the opportunity to fulfill another clearly defined but unmet patient need in atrial fibrillation, an important focus area of the company’s overall developmental activity:
* Medtronic's wide array of ablation therapeutic options and tools, released worldwide, include the Atakr® II RF power generator, advanced catheters such as the RF Marinr® MC and the new RF Conductr® MC and the Stablemapr™, an advanced duo-decapolar diagnostic device. Also available in Europe and select geographies outside the U.S. are Medtronic's Amazr® 6 pole linear lesion catheter for the treatment of atrial fibrillation and the Sprinklr™ irrigated tip catheter for the treatment of ventricular tachycardia and atrial flutter.
* The Vitatron Selection™ AFm (Model 902), released in the U.S. market last fall, is the first pacing system with new monitoring capabilities to help physicians more effectively manage and treat atrial fibrillation by helping to precisely target its onset in each individual patient.
* The Medtronic AT500™ pacing system, with its exclusive AT™ Trio of capabilities designed to monitor, intervene and treat atrial arrhythmias in patients with bradycardia, is commercially available in Europe and Canada while under clinical investigation in the United States.
* The Medtronic GEM® III AT implantable defibrillator is designed to offer comprehensive therapies and diagnostic tools for physicians treating heart patients with atrial tachyarrhythmias and/or life-threatening ventricular tachyarrhythmias. The device is commercially released in Europe and the U.S. The GEM III AT includes the proprietary AT Trio designed to monitor, intervene and terminate atrial tachyarrhythmias.
Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.
