October 2003 Press Releases

CryoCor Progresses in Clinical Studies Medtronic Expands Heart Devices Available St. Jude Medical Announces ASSIST Clinical Trial Atrial Fibrillation Phase I Enrollment Complete, Atrial Flutter Phase II Feasibility Trial Begins CryoCor, Inc., a development stage medical technology company, announced the completion of U.S. patient enrollment of the first phase of the feasibility trial for paroxysmal atrial fibrillation and the initiation of additional enrollment in the feasibility trial for atrial flutter at Arizona Heart Hospital and at Iowa Heart Center, two of the ten centers involved in this study. Atrial fibrillation is the most common cardiac arrhythmia, afflicting over 2 million people in the US and over 5 million worldwide. Those stricken with atrial fibrillation (which causes the heart to beat in a rapid, chaotic fashion) experience over five times the normal rate of stroke and twice the normal death rate. Atrial flutter is the second most commonly occurring cardiac arrhythmia and often progresses to (or co-exists with) atrial fibrillation. We are pleased that the CryoCor Cardiac Cryoablation System continues to progress through the clinical trial pathway towards U.S. approval, said Dr. Gregory M. Ayers, CryoCor President and Chief Executive Officer. Our progress in the clinic has allowed us to secure financing, to strengthen our management team and begin to build overall physician confidence that the CryoCor System provides a promising minimally invasive therapy to serve the arrhythmia ablation market. Atrial Flutter Study At Arizona Heart Hospital, a new study center, Dr. David W. Riggio, MD, Assistant Director of Electrophysiology, Arizona Arrhythmia Consultants, treated the first patient under the Phase II feasibility trial for atrial flutter with the CryoCor Cardiac Cryoablation System. I m very pleased with the entire technique and delivery system. The catheter is quite easy to position and the freezing process was accurate and effortless. I thought it was very easy to use, said Dr. Riggio. Our patient was successfully treated using CryoCor s new technology. We see many benefits and are looking forward to treating many more patients with atrial flutter.Additionally, one patient was treated under the same protocol at the Iowa Heart Center in Des Moines, Iowa, by Dr. Robert Hoyt. Earlier this year, CryoCor completed enrollment of 30 patients under the Phase I U.S. feasibility trial. The company expects to complete the 20-patient enrollment for the Phase II atrial flutter feasibility trial by fourth quarter 2003, following which the company intends to proceed with a pivotal trial necessary to support a U.S. Premarket Approval (PMA) application to the FDA. Atrial Fibrillation Study The company reported that in the U.S., thirty-one patients have been treated and enrollment is complete for the feasibility trial with use of the CryoCor System. As per the feasibility trial protocol, up to 6-month patient follow-up for safety and efficacy is currently being conducted with these patients. Additionally, the company expects to file for FDA approval to expand enrollment in the U.S. paroxysmal atrial fibrillation feasibility trial using CryoCor s second generation cryoablation catheter. New Research on Treating Atrial Fibrillation with Cryoablation The company also announced in a recent issue of the Journal of the American College of Cardiology, that over long-term follow-up, the use of the CryoCor System in the electrical isolation of pulmonary veins is feasible and may prevent arrhythmia recurrence in atrial fibrillation patients without the occurrence of pulmonary vein stenosis. The publication reports that the safety profile of the CryoCor System was better than voluntarily reported complication rates in non-controlled trials using radiofrequency energy 7.7% with use of the CryoCor System as compared to 8% to 35% using radiofrequency energy. No pulmonary vein stenosis was reported after 12-month patient follow-up. This complication of radiofrequency ablation, in severe cases, can lead to the need for additional procedures. The publication also reports that, based on long-term follow-up of 52 patients for a mean of 12.4 months, 71% of patients with prior chronic or paroxysmal atrial fibrillation had no recurrences or were clinically improved following treatment. In a sub-set of 45 patients diagnosed with paroxysmal atrial fibrillation, 58% of these patients were free of arrhythmia at 12 months. Clinical Management Team Strengthened Ruchir Sehra, MD, FACC, has joined CryoCor as Medical Director. Dr. Sehra will be responsible for managing the company s Clinical Affairs Department, including the activities in clinical studies, regulated clinical trials, research publications and abstracts. Dr. Sehra brings more than 12 years of electrophysiology and cardiology experience. He has held numerous academic and professional positions at Loma Linda University, where he served most recently as Associate Professor of Pediatrics and Medicine. While at Loma Linda University, he developed the Clinical Research Division, served as Institutional Review Board member and was a clinical trial site principal investigator in five multicenter clinical trials and co-investigator in 10 additional trials both in pharmaceuticals and medical devices. He also was Director of Business Operations where he oversaw business and financial issues of the physician practice with revenues of over $15 million a year. Number of Patients Using the System has Doubled in 3 Months As physicians face challenges in efficiently managing their growing patient population, Medtronic, Inc. is expanding the number of implantable heart devices that can be monitored remotely using its Medtronic CareLink Network. As a result, physicians now can manage more device patients via an enhanced Internet website while their patients relax or work across the city, state or country. Medtronic simplified the cardiac device follow-up process for physicians and patients when it introduced the Medtronic CareLink Network in early 2002, and clinics now are following thousands of implantable cardioverter-defibrillator (ICD) patients nationwide using the technology. This week, clinics can offer access to the Network for patients who have a Marquis ® VR single-chamber ICD, the most advanced Medtronic single-chamber ICD available to stop fast heart rates and revive patients from sudden cardiac arrest. My staff has nearly 250 patients who are now primarily managed from the convenience of their homes. I am impressed with Medtronic s ability to rapidly add new devices to the CareLink Network, a system that allows us to cost-effectively improve the management of our increasing patient volume and the quality of patient care we provide, said electrophysiologist W. Ben Johnson, MD from the Des Moines-based Iowa Heart Center. We view remote telemetry, such as that provided by the CareLink Network, as the new standard of care for ICD patients. I expect the technology to increasingly change the way patients with implantable devices are cared for across the country. Available in all 50 states, the Medtronic CareLink Network is an Internet-based service that enables physicians to check on the heart function and device performance of patients who have an ICD by accessing data on a website. Using the Medtronic CareLink Monitor, patients collect the data by holding a small antenna over their implanted device. The monitor automatically downloads the data and sends it through a standard telephone connection directly to a secure server, and clinicians access patient data by logging onto the clinician website from any Internet-connected computer. With physician approval, patients and their family members can view device and heart condition information on a personalized website. In the past three months, the number of patients using the Medtronic CareLink Network has doubled, and the technology quickly is becoming a trusted solution for hospitals and clinics nationwide. With the addition of the Marquis VR, we fully expect this trend to escalate, said Reggie Groves, Vice President and General Manager of Medtronic Patient Management. We re very excited about the benefits being realized by clinicians and their patients. From better care through diagnoses of previously undetected heart rhythm problems to improved cost-efficiencies and added convenience, the Network is empowering health care providers to improve lives. ® Medtronic recently received clearance from the U.S. Federal Drug Administration to use the Medtronic CareLink Monitor with the Marquis VR ICD, which provides faster therapy delivery than competitive devices. This announcement marks a milestone in the company s plans to include its latest ICDs on the Medtronic CareLink Network. In conjunction with the launch of the Marquis VR device on the Medtronic CareLink Network, physicians and nurses now can use the Network s clinician website to access historical performance data about device leads (wires) and diagnostic information for patients with any of the Marquis ® DR/VR or GEM ® III DR/VR ICDs. In addition, clinicians following patients with a Marquis VR ICD can access data on the website from the device, including information about the Wavelet algorithm that discriminates between types of arrhythmias and can help physicians determine optimum treatment solutions. St. Jude Medical Inc. announced the initiation and first patient enrollment in the ASSIST (Atrial Tachyarrhythmia Suppression Strategy in ICD Subjects Trial) clinical study. The purpose of the ASSIST study is to evaluate if atrial fibrillation (AF) suppression pacing in dual-chamber ICD patients will reduce atrial arrhythmia burden and the frequency of inappropriate VT/VF therapy in patients with a history of paroxysmal atrial fibrillation. The patient received a St. Jude Medical Epic+ DR implantable cardioverter defibrillator (ICD), the ICD with clinically proven AF Suppression technology. By including AF Suppression pacing in this small dual-chamber ICD, we are able to provide patients with two important therapies without compromising overall performance, said Demos Iskos, MD, who performed the first implant in the ASSIST study using an Epic+ DR ICD (Model V-236) at McKay-Dee Hospital Medical Center in Ogden, Utah. The procedure went as expected and the patient, a 65-year-old male, is doing well. ASSIST is the first study to evaluate the impact of St. Jude Medical's AF Suppression algorithm with an ICD patient population, said Dr. Roy Sauberman, Principal Investigator of the ASSIST clinical trial at Newark Beth Israel Medical Center in Newark, New Jersey. This is a significant study for physicians who treat patients with both atrial and ventricular tachyarrhythmias, because AF can affect the functioning of an ICD as well as a patient's overall quality of life. Our AF Suppression technology has already been proven clinically effective in reducing AF burden, said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management business. We hope to demonstrate that this technology can also reduce the incidence of inappropriate therapy delivered to patients suffering from ventricular tachyarrhythmias, bradyarrhythmias and atrial tachyarrhythmias. The ASSIST trial is a randomized study being conducted at 40 centers across the country. Patients will be divided into AF Suppression algorithm ON and AF Suppression algorithm OFF groups. The trial is estimated to last two years to achieve the study population. To be included in the study, patients must have a standard indication for a dual chamber ICD, be in sinus rhythm (or cardioverted into sinus rhythm) at time of ICD implant, and have a recent episode (within six months) of paroxysmal AF. A stable anti-arrhythmic medication regimen will be maintained during the clinical trial. Patients with chronic AF (unable to cardiovert into sinus rhythm) are not included in the study.