Healthcare Industry News: INOVATE-HF
News Release - April 26, 2011
BioControl Medical Launches the INOVATE-HF IDE Study of Its CardioFit(R) System for Heart Failure
YEHUD, Israel & NEW HOPE, Minn.--(Healthcare Sales & Marketing Network)-- BioControl Medical, a medical technology company that develops and markets advanced implantable devices for the treatment of autonomic disorders, has announced first patient enrollment in the INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) clinical study at Northwest Texas Heart Hospital, Amarillo, Texas, by study investigator Suresh Neelagaru, M.D.INOVATE-HF is a global, multi-center investigational device exemption (IDE) clinical study to determine the safety and efficacy of BioControl Medical’s CardioFit® system, an implantable electrical stimulation device designed to improve heart function in patients with congestive heart failure (HF).1 The prospective, randomized, controlled study is designed to evaluate the system’s potential to reduce hospitalization and death among patients with HF, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone. Results of the study will be used to support a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for market clearance of CardioFit.
HF currently affects approximately 23 million people worldwide and is diagnosed in two million new cases each year.2 The leading cause of hospitalization in people over age 65, HF is also the most rapidly growing cardiovascular disorder in the United States.2,3 Most HF patients are treated with prescription drugs that are successful at managing select symptoms but are ultimately unable to stop HF deterioration. CardioFit was developed to address this unmet clinical need by directly activating a specific part of the body’s nervous system (called the “parasympathetic” nervous system) to reduce stress on the heart, thereby alleviating HF symptoms and reversing HF deterioration. It operates by stimulating the vagus nerve on the right side of the neck.
“The first patient enrollment in INOVATE-HF marks an exciting milestone for BioControl Medical,” said Ehud Cohen, Ph.D., chief executive officer of BioControl Medical. “While the results of earlier studies of the CardioFit have suggested that vagal nerve stimulation may have added therapeutic value over and above traditional treatments for HF, INOVATE-HF will allow physicians to investigate its potential benefits among a large group of patients.”
INOVATE-HF is enrolling up to 650 patients at up to 80 centers in the United States and Europe. Patients are randomized on a three-to-two basis with the CardioFit or ongoing prescription drug therapy. The primary efficacy endpoint is time to first occurrence of unplanned HF hospitalization or all-cause death. The primary safety endpoints are system-related complications within 90 days of implantation and non-inferiority to prescription drug therapy beyond 90 days. Secondary endpoints include the rate of unplanned HF hospitalization as well as the change from baseline to 12 months in HF symptoms as well as functional and structural cardiovascular status.
“Every decade, researchers seek to uncover new methods, medications and technologies to advance the treatment of heart failure, but so often the results represent only incremental improvement. I believe this will change with the INOVATE-HF study of the CardioFit system,” said Dr. Neelagaru, a cardiac electrophysiologist. “By giving us the ability to directly treat the parasympathetic nervous system, the CardioFit has the potential to deliver paradigm-shifting improvement for patients with HF. Exploration of the mind-heart connection is appealing on many levels, but this technology represents a thoroughly exciting new electrical approach to modulating the autonomic nervous system without medications. Investigation of the CardioFit device is as exciting as the adoption of beta blocking medications as a treatment modality in the late 1990s.”
About the CardioFit
The CardioFit system consists of a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. The sensor lead is extended from the stimulator to the right ventricle of the heart, and the stimulation lead is extended from the stimulator to the vagus nerve on the right side of the neck. Once activated, the stimulator’s electrical pulses are transferred via the stimulation lead to the vagus nerve. At the same time, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly. Like a pacemaker, the CardioFit System can be programmed on and off via external wireless communication with the device.
The safety and performance of the CardioFit have been validated in a 32-patient, multi-center, pilot clinical study conducted in Germany, Italy, The Netherlands and Serbia.4 Study data showed that patients experienced sustained significant improvement across key clinical measures including left ventricular function and structure, heart rate variability, and resting heart rate.4 Patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests.4 The results of this pilot study supported BioControl Medical’s filing for CE mark certification to market and sell CardioFit in the European Union, which it was granted in December 2008.
About BioControl Medical
Headquartered in Yehud, Israel with offices in New Hope, Minn., BioControl Medical develops and markets advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results. For more information on BioControl Medical, visit www.biocontrol-medical.com.
1 CardioFit is limited to investigational use only by the U.S. Food and Drug Administration
2 Congestive Heart Failure: Worldwide Drug and Medical Device Market – Kalorama Information available through MarketResearch.com
3 American Heart Association
4 De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ. “Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure.” Eur Heart J (2011) 32 (7): 847-855.
Source: BioControl Medical
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