Clinical Trial for Gatekeeper Reflux Repair System
Tuesday November 18, 2003
Medtronic, Inc announced the start of the U.S. pivotal clinical trial for the Gatekeeper(TM) Reflux Repair System, the company's endoscopic therapy for the treatment of gastroesophageal reflux disease (GERD), or acid reflux.
Press Release:
November 18, 2003 01:22 PM US Eastern Timezone
Medtronic Announces Start of U.S. Pivotal Clinical Trial for Gatekeeper Reflux Repair System; Endoscopic Therapy for GERD Designed to Reduce Acid Reflux and Heartburn
MINNEAPOLIS--(BUSINESS WIRE)--Nov. 18, 2003--Medtronic, Inc. (NYSE:MDT), today announced the start of the U.S. pivotal clinical trial for the Gatekeeper(TM) Reflux Repair System, the company's endoscopic therapy for the treatment of gastroesophageal reflux disease (GERD), or acid reflux. GERD is a condition that affects 21 million Americans.
"Gatekeeper Therapy may have the potential for reducing patients' dependence on medications and improving their GERD symptoms," said Dr. Bergein Overholt of Gastrointestinal Associates, PA, in Knoxville, Tenn., who performed the first U.S. pivotal study clinical implant of Gatekeeper Therapy on a 28-year old male patient without complication. "The Gatekeeper option is also less invasive than existing surgical procedures to treat GERD."
The trial is designed to demonstrate the ability of Gatekeeper Therapy to relieve symptoms in patients diagnosed with GERD. The trial will include 144 patients in a randomized, single-blinded study. Importantly, this is the first clinical trial of an endoscopic therapy to treat GERD that will measure the placebo effect prior to submission to the U.S. Food and Drug Administration. Patients' outcomes will be evaluated after six and 12 months for safety, improved levels of esophageal acid levels, heartburn symptoms, quality of life and reduction of GERD-related medications. At the six-month endpoint, the blind will be broken, and patients who received the controlled (placebo) procedure will have the option to receive Gatekeeper Therapy.
The Gatekeeper System consists of an endoscopic delivery system and individual prostheses made of a biocompatible material (similar to the substance used in contact lenses). Although dry when inserted near the lower esophageal sphincter, the prostheses expand upon contact with moisture. In effect, this creates a barrier that is designed to allow food and liquids to pass normally into the stomach, while restricting acid and other stomach contents from refluxing back up into the esophagus.
During the clinical trial, acid levels in the esophagus will be measured using Medtronic's Bravo(TM) pH Monitoring System, a catheter-free technique that allows patients to engage in normal daily activities while their acid levels are monitored. The Bravo System, which extends the recording interval of pH tests to 48 hours, 24 hours beyond conventional nasal catheter systems, provides more representative data of a patient's typical day to allow for more accurate diagnoses. Delivered and placed following endoscopy, the Bravo System consists of a capsule that is temporarily placed in the esophageal wall and transmits pH data through radiotelemetry to a pager-sized receiver worn by the patient. The Bravo pH Monitoring System has been commercially available in the US since September 2000.
Candidates for the clinical trial of Gatekeeper Therapy include patients diagnosed with acid reflux who show symptomatic improvement to traditional drug therapy, but who want to discontinue their GERD medication(s). The procedure is typically performed on an outpatient basis, and in most cases multiple prostheses are used.
"The Gatekeeper System is performed with endoscopic view controlling implant sites. Usually, only one pass of the endoscope is required. Unlike some other endoscopic therapies, the prostheses are removable if necessary," said Dr. Glen Lehman of the Indiana University School of Medicine in Indianapolis, another investigator participating in the clinical study. "This study is extremely important because it will enable us to measure the placebo effect in GERD patients and to determine the safety and efficacy of Gatekeeper Therapy in a large patient population."
A common disorder characterized by serious heartburn and acid regurgitation, GERD is caused when the lower esophageal sphincter (LES) -- the junction between the esophagus and the stomach -- becomes weak and ineffective, allowing stomach contents to reflux into the esophagus. Untreated, it can lead to inflammation and injury of the esophagus or a potentially pre-cancerous condition called Barrett's esophagus.
The Medtronic suite of technologies that are available for the diagnosis and treatment of gastrointestinal conditions includes the Bravo(TM) pH Monitoring System and Enterra(TM) Therapy for the treatment of gastroparesis.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Patients can obtain more information about GERD and Gatekeeper Therapy by calling 1-800-664-5111.
Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.
EDITOR'S NOTE:
More information about GERD can be found at ww.medtronic.com/neuro/gerd/whatisgerd.html.
More information about Medtronic's Bravo(TM) pH Monitoring System can be found at www.medtronic.com/neuro/gerd/explainproced.html.
Contacts
Medtronic, Inc., Minneapolis
Media:
Kathleen Janasz, 763-505-2634
kathleen.janasz@medtronic.com
or
Analysts:
Rachael Scherer, 763-505-2694
rachael.scherer@medtronic.com
Press Release:
November 18, 2003 01:22 PM US Eastern Timezone
Medtronic Announces Start of U.S. Pivotal Clinical Trial for Gatekeeper Reflux Repair System; Endoscopic Therapy for GERD Designed to Reduce Acid Reflux and Heartburn
MINNEAPOLIS--(BUSINESS WIRE)--Nov. 18, 2003--Medtronic, Inc. (NYSE:MDT), today announced the start of the U.S. pivotal clinical trial for the Gatekeeper(TM) Reflux Repair System, the company's endoscopic therapy for the treatment of gastroesophageal reflux disease (GERD), or acid reflux. GERD is a condition that affects 21 million Americans.
"Gatekeeper Therapy may have the potential for reducing patients' dependence on medications and improving their GERD symptoms," said Dr. Bergein Overholt of Gastrointestinal Associates, PA, in Knoxville, Tenn., who performed the first U.S. pivotal study clinical implant of Gatekeeper Therapy on a 28-year old male patient without complication. "The Gatekeeper option is also less invasive than existing surgical procedures to treat GERD."
The trial is designed to demonstrate the ability of Gatekeeper Therapy to relieve symptoms in patients diagnosed with GERD. The trial will include 144 patients in a randomized, single-blinded study. Importantly, this is the first clinical trial of an endoscopic therapy to treat GERD that will measure the placebo effect prior to submission to the U.S. Food and Drug Administration. Patients' outcomes will be evaluated after six and 12 months for safety, improved levels of esophageal acid levels, heartburn symptoms, quality of life and reduction of GERD-related medications. At the six-month endpoint, the blind will be broken, and patients who received the controlled (placebo) procedure will have the option to receive Gatekeeper Therapy.
The Gatekeeper System consists of an endoscopic delivery system and individual prostheses made of a biocompatible material (similar to the substance used in contact lenses). Although dry when inserted near the lower esophageal sphincter, the prostheses expand upon contact with moisture. In effect, this creates a barrier that is designed to allow food and liquids to pass normally into the stomach, while restricting acid and other stomach contents from refluxing back up into the esophagus.
During the clinical trial, acid levels in the esophagus will be measured using Medtronic's Bravo(TM) pH Monitoring System, a catheter-free technique that allows patients to engage in normal daily activities while their acid levels are monitored. The Bravo System, which extends the recording interval of pH tests to 48 hours, 24 hours beyond conventional nasal catheter systems, provides more representative data of a patient's typical day to allow for more accurate diagnoses. Delivered and placed following endoscopy, the Bravo System consists of a capsule that is temporarily placed in the esophageal wall and transmits pH data through radiotelemetry to a pager-sized receiver worn by the patient. The Bravo pH Monitoring System has been commercially available in the US since September 2000.
Candidates for the clinical trial of Gatekeeper Therapy include patients diagnosed with acid reflux who show symptomatic improvement to traditional drug therapy, but who want to discontinue their GERD medication(s). The procedure is typically performed on an outpatient basis, and in most cases multiple prostheses are used.
"The Gatekeeper System is performed with endoscopic view controlling implant sites. Usually, only one pass of the endoscope is required. Unlike some other endoscopic therapies, the prostheses are removable if necessary," said Dr. Glen Lehman of the Indiana University School of Medicine in Indianapolis, another investigator participating in the clinical study. "This study is extremely important because it will enable us to measure the placebo effect in GERD patients and to determine the safety and efficacy of Gatekeeper Therapy in a large patient population."
A common disorder characterized by serious heartburn and acid regurgitation, GERD is caused when the lower esophageal sphincter (LES) -- the junction between the esophagus and the stomach -- becomes weak and ineffective, allowing stomach contents to reflux into the esophagus. Untreated, it can lead to inflammation and injury of the esophagus or a potentially pre-cancerous condition called Barrett's esophagus.
The Medtronic suite of technologies that are available for the diagnosis and treatment of gastrointestinal conditions includes the Bravo(TM) pH Monitoring System and Enterra(TM) Therapy for the treatment of gastroparesis.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Patients can obtain more information about GERD and Gatekeeper Therapy by calling 1-800-664-5111.
Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.
EDITOR'S NOTE:
More information about GERD can be found at ww.medtronic.com/neuro/gerd/whatisgerd.html.
More information about Medtronic's Bravo(TM) pH Monitoring System can be found at www.medtronic.com/neuro/gerd/explainproced.html.
Contacts
Medtronic, Inc., Minneapolis
Media:
Kathleen Janasz, 763-505-2634
kathleen.janasz@medtronic.com
or
Analysts:
Rachael Scherer, 763-505-2694
rachael.scherer@medtronic.com
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