SUNNYVALE, Calif.--(BUSINESS WIRE)--EBR Systems, Inc., a privately held clinical stage company, announced today the first human implants of the WiCS® Wireless Cardiac Stimulation System. The WiCS® cardiac pacing system represents a significant medical breakthrough, eliminating the cardiac pacing lead by stimulating the heart through wireless transmission of energy. This technology has the potential to revolutionize the future of cardiac pacing. These first implants mark the beginning of the WiSE-CRT (Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy) clinical trial sponsored by EBR Systems.
The first human implant in the world occurred at Isala Kilinieken in Zwolle, NL, by Dr. Peter Paul Delnoy. The patient, who met clinical guidelines for cardiac resynchronization therapy (CRT), was a 69 year old male with ischemic heart disease, class 3 heart failure and prolonged QRS who had a previously implanted St Jude Medical dual chamber ICD (in 2008). The WiCS wireless cardiac stimulation system, together with the previously implanted dual chamber ICD, successfully upgraded the patient to cardiac resynchronization therapy, without disruption or premature replacement of the functional ICD system. Thirty day follow-up of the patient and the system demonstrated acute CRT pacing confirmed electrically by EKG and hemodynamically by echocardiography. Dr. Delnoy also implanted a second upgrade patient, a 65 year old patient meeting standard guidelines for CRT and had a previously implanted Medtronic ICD.
Dr Christian Butter at Herzzentrum Brandenburg Hospital in Bernau bei Berlin performed the first two implants of the WiCS system in Germany. The system was implanted in a 59 year old male with ischemic heart disease, also as part of the WiSE-CRT trial. The WiCS system was co-implanted with a previously implanted Medtronic CRT device (in 2008). The coronary sinus (CS) lead implanted in 2008 with the CRT device had stopped pacing the heart, and a thrombotic occlusion precluded replacement of the CS lead, despite attempts to re-open the occluded vein. The use of WiCS pacing system allowed an alternative to the coronary sinus lead to deliver CRT therapy. Following successful implantation of the WiCS system, the patient demonstrated successful biventricular pacing and capture of the left ventricle, as evidenced by EKG morphology changes and shortening of the QRS complex. The second patient, a 78 year old male with ischemic heart disease, and left ventricular ejection fraction (EF) of 25% was also implanted with the WiCS pacing system. This patient had been previously implanted with a Medtronic CRT system, however, infection required explantation of the pacing lead, and no CS lead was able to be re-implanted, despite multiple attempts by several different physicians. Patient follow up was done prior to discharge confirming a successful implant and delivery of CRT therapy.
“Both of these patients had previous attempts to implant cardiac resynchronization therapy that failed, due to the challenges and limitations of implanting left heart leads through the coronary sinus. Implanting a wireless electrode in the left ventricle provides a solution for many patients previously being denied therapy,” said Dr. Christian Butter, Chief of Cardiology, Herzzentrum Brandenburg.
“We are excited to have achieved this important milestone in the field of cardiac rhythm management, the elimination of a pacing lead for cardiac stimulation. 2011 marks the beginning of a new era in cardiac pacing and opens up a wide range of opportunities, WiCS will play an important role in changing cardiac stimulation therapy enabling multi-site stimulation, site specific pacing, and leadless pacing,” said Rick Riley, CEO EBR Systems, Inc.
About EBR Systems The WiCS technology was developed by EBR Systems to address the significant opportunity to eliminate cardiac pacing leads, historically a major source of complications and reliability issues. The initial product application focuses on the important underserved need in the heart failure population. This population is underpenetrated by CRT therapy, despite numerous clinical trials illustrating these therapies benefits. Part of the reason for low penetration is the complexity of the procedure; the complications associated with coronary sinus leads used to pace the LV, and continued non-responder rates of approximately 30% despite advances in LV lead technology. CS leads are placed through the coronary sinus to access the cardiac venous structure on the epicardial surface of the heart. WiCS approaches resynchronization therapy physiologically, recognizing that the site of stimulation has an impact on responder rates, and the physiologic benefit of endocardial vs. epicardial stimulation is significant. The procedure is simple, resulting in predictable implant times. Stimulating the endocardial surface eliminates a myriad of complications associated with CS leads: acute and chronic lead dislodgement, CS dissection, acute and chronic phrenic nerve stimulation, and high pacing energy thresholds. The result is an elegant solution for a large number of heart failure patients indicated for CRT therapy: those patients implanted with an existing pacemaker or defibrillator and would benefit from upgrading their therapy, those patients denied therapy with failed attempts to implant a CS lead, and the large number of patients who are classified as non-responders or marginal responders.
About the WiSE-CRT WiSE-CRT is a 100 patient feasibility and safety trial being conducted in Europe demonstrating biventricular pacing capture with WiCS. Dr. Angelo Aurrichio is the Principle Investigator for the study, along with the WiSE-CRT steering committee comprised of Prof. Dr. Johannes Brachmann and Prof. Dr. Jean-Claude Daubert.
About Heart Failure/Cardiac Resynchronization Therapy Heart failure affects greater than 5 million Americans and 22 million people worldwide; heart failure is the most costly cardiovascular disease in the US, estimated at $40B/year and growing. Cardiac resynchronization therapy is a treatment for heart failure that uses an implantable device to improve the pumping efficiency of the heart by synchronizing the ventricles of the heart. Studies have demonstrated successful CRT therapy improves symptoms, reduces hospitalizations and reduces mortality.