Cardiogenesis has gained European approval for the commercial sale of the Pearl Minimally Invasive transmyocardial revascularisation (TMR) delivery systems.
The Pearl Robotic 5.0 and Thoracoscopic 8.0 delivery systems are designed to reduce the morbidity and recovery time for patients, while providing the same improved long term survival and enduring angina benefit achieved with the standard Cardiogenesis Ho:YAG surgical system.
Dr Gary S Allen, the Principal Investigator for the Pearl 8.0 Thoracoscopic Study in the US stated, "These advanced minimally invasive tools for TMR are necessary additions to the cardiothoracic surgeon's armamentarium in achieving total revascularisation. The Ho:YAG fibre-optic platform is the only commercially available TMR system which allows for true port access laser revascularisation. Patient outcomes have been superior compared to historical experiences, with many patients returning home within 48 hours of surgery. Compared to other minimally invasive cardiac operations, port access TMR has a shorter learning curve, less contraindications and requires fewer hospital resources. The substantially less-invasive surgical profile has rapidly led to increased patient and physician acceptance, and will likely replace traditional 'open' procedures as the standard of care for sole therapy TMR."
The minimally invasive Pearl delivery systems are currently under investigation in the United States. Cardiogenesis is currently enrolling patients in a small safety and feasibility trial in support of the FDA approval process. The company expects to complete enrolment in the study during the first quarter of 2006.
Michael J Quinn, Chairman and CEO, said, "Physicians will now be able to offer the impressive clinical benefits of TMR to patients, with reduced surgical incisions and a more rapid recovery. We believe that this minimally invasive surgical platform offers the opportunity to re-launch sole therapy surgical TMR in Europe with the leaders in advanced cardiothoracic techniques. Patients throughout Europe now have access to our advanced surgical and percutaneous devices and techniques, which have been proven to decrease morbidity rates compared to the traditional open surgical techniques."
Separately, ESTECH has released its range of Cobra products that are used surgically to treat atrial fibrillation (AF). ESTECH claims its Cobra line of products are the first ablation devices available that have received clearance to be marketed specifically for AF.
The Cobra, Cobra Adhere XL and the Cobra Bipolar Pacing Probe have recently received FDA marketing clearance. The Cobra Adhere Surgical System received the CE mark with an indication for treatment of AF and is used by surgeons to make lesions on the heart that block the electrical impulses that cause AF. The Cobra Adhere XL will enable a minimally invasive technique to treat AF. The Cobra Bipolar Pacing Probe is the first RFA accessory in the US and Europe to be intended for the treatment of cardiac arrhythmias. It provides a means for immediately evaluating the effectiveness of AF treatment procedures.
Cobra technology uses a unique intelligent temperature based system that provides both optimal and reproducible results by regulating the RF energy. ESTECH claims that other systems offered by AtriCure, Medtronic and Guidant do not have this advanced energy regulation technology.
Staying in the AF segment, ProRhythm has received the CE mark for its High Intensity Focused Ultrasound (HIFU) ablation system for the treatment of AF.
ProRhythm's proprietary balloon catheter to treat tissue in the left atrium of the heart is used in an AF ablation procedure commonly called pulmonary vein isolation. The HIFU balloon is inserted through a vein in the leg of the patient and advanced into the left atrium. Controlled, discrete ablation lesions around the pulmonary veins, created with the HIFU catheter and controlled by ProRhythm's proprietary automated system, stop unwanted electrical impulses from disrupting the heart's normal rhythm.
Unlike other energy forms used for this procedure, HIFU energy is non-thrombogenic and is focused in order to create transmural lesions within the myocardium, the company claims. European clinical trials have demonstrated that a significant percentage of patients undergoing the HIFU ablation procedure have experienced a complete elimination of AF episodes with a single treatment procedure. The HIFU system will be marketed through ProRhythm's exclusive distributor for Europe, SJM International, a subsidiary of St Jude Medical.
Professor Karl-Heinz Kuck, of St Georg Hospital in Hamburg, Germany, who acted as the Principal Investigator for the European clinical study said, "Our clinical experience with the HIFU system has demonstrated the ability of HIFU to isolate pulmonary veins and reduce or eliminate AF. The HIFU ablation system provides the clinician with a promising tool to treat patients who suffer from AF."
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