LOS ANGELES, June 20 /PRNewswire/ -- Savacor, Inc., a developer of innovative, permanently implantable intracardiac monitoring systems for the treatment of congestive heart failure (HF), today announced that the first five patients have been enrolled in the company's HOMEOSTASIS I clinical trial. The HOMEOSTASIS I trial (HemOdynaMically guidEd hOme Self-Therapy in Severe heart faIlure patientS) is a first-in-man feasibility trial designed to evaluate the preliminary safety, functionality and efficacy of the HeartPOD(TM) Implantable Heart Failure Therapy System in twenty patients with congestive heart failure at up to four international sites. All five of the patients were successfully implanted at Christchurch Hospital, Christchurch, New Zealand. The research team in New Zealand was headed by Dr. Richard Troughton, one of trial's Principal Investigators. The implanting electrophysiologists were Drs. Iain Melton and Ian Crozier. The first three patients have reached the primary trial endpoint at six weeks after implantation. All patients are doing well, with no major adverse cardiac or neurological events. No patient has evidenced clinical deterioration. The implanted sensors, external hardware and software have performed according to specification. Follow-up information will be gathered at quarterly clinic visits.
The HeartPOD(TM) System is a proprietary medical device consisting of a permanently implanted intracardiac sensor that allows the patient to directly monitor left atrial pressure, the intracardiac electrogram, and core body temperature. The implant's readings are communicated with a hand-held computer called a Patient Advisory Module, or PAM. The information is used to adjust medications on a dose-by-dose basis according to the patient's physician's prescriptive instructions. This permits real-time adjustment and dosing of medication similar to the way diabetics adjust insulin dosage in response to home glucose monitoring. Left atrial pressure is believed to be a key measurement for predicting acute worsening of HF that leads to lung congestion and the need for urgent hospitalization. The device is implanted by a minimally invasive cardiac catheterization procedure, similar to pacemaker insertion. Enrollment is anticipated to be completed in the fall of 2005.
"We are excited to be part of the initiation of this first human experience evaluating Savacor's unique heart failure system," said Dr. Troughton. "Starting with the very first patient, we have gained new insight into the dynamic cardiac changes that occur on a daily basis in our patients. We are hopeful that real-time monitoring will allow us to better treat our patients and to minimize complications, such as recurrent hospitalization, acute pulmonary edema and renal failure."
"We are very pleased to have begun this important trial with leading clinical investigators from around the world," said Neal Eigler, MD, CEO and co-founder of Savacor. "This early-phase trial will help gather information
necessary for larger-scale investigations needed for regulatory approvals in the U.S. and other countries."
According to William Abraham, MD, FACC, the study's Chairman and Chief of Cardiology at The Ohio State University, Columbus, Ohio, "Left atrial pressure is the measurement we've been waiting for because when it is too high, it is the proximate cause of water accumulating in the lungs, which is responsible for 90% of HF hospitalizations and when it is too low, damage to the kidneys may occur, which carries a three to four-fold increase in mortality. HOMEOSTASIS I is expected to demonstrate for the first time in human trials whether daily optimization of drug therapy may improve clinical outcome in HF by preventing both over- and under-treatment. This has important implications for future trends in HF management, as preventing hospitalization is likely to be cost effective." The impact of this can be significant when considering that in the U.S. alone, about 5 million patients suffer from HF and almost one million are hospitalized annually. HF carries a mortality rate similar to cancer and one in five patients with HF die within one year of diagnosis. The annual cost to the U.S. healthcare system is over $40 billion. The number of patients contracting HF is expected to double within the next decade as baby boomers age and develop heart disease.
Savacor, Inc. develops innovative technologies for monitoring and treating patients with cardiovascular diseases. For further information on Savacor, visit www.savacor.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation, the statements related to clinical development and potential regulatory approval of the HeartPOD System. All forward-looking statements and other information included in this press release are based on information available to Savacor as of the date hereof, and the Company assumes no obligation to update any such forward-looking statements or information. The company's actual results could differ materially from those described in the company's forward-looking statements.
CAUTION: The HeartPOD(TM) System is not available for sale in the United States or other countries. The HeartPOD System is an investigational device, limited by United States law to investigational use.