Tweet
News from Medtronics re: interstim!
MINNEAPOLIS —Sept. 26, 2001 —Medtronic, Inc. (NYSE: MDT), today announced the U.S. Food and Drug Administration’s approval of an accurate screening test to identify people who may benefit from InterStim Therapy for Urinary Control, a treatment for intractable voiding dysfunction that uses an implanted medical device akin to a cardiac pacemaker to deliver sacral nerve stimulation.
The FDA’s approval is based on the results of a multicenter clinical study, which demonstrated that the new approach to screening prospective patients adds a high predictive value, accurately revealing InterStim Therapy to be a viable treatment option for patients who previously were not considered candidates due to earlier inconclusive test results. The newly approved test uses a surgically placed lead —a thin, insulated wire with electrodes at one end —that can remain implanted if the test result is positive. Patients who experience a clinically significant reduction in symptoms during the screening trial may choose to proceed with the treatment.
The new screening test is approved for use with patients who had inconclusive results following testing with the earlier percutaneous testing technique. InterStim Therapy is indicated for refractory cases of urinary urge incontinence, significant symptoms of urgency frequency and nonobstructive urinary retention.
In the past, many patients have had inconclusive results following testing with a percutaneously placed, temporary test-stimulation lead. Because of the way it is placed, the percutaneous lead can move, yielding false negatives or inconclusive results. More recently, clinical researchers have determined that the percutaneous lead used in earlier screenings could move after placement and may yield false negatives or inconclusive results.
"Inconclusive test results, which often occur due to lead migration, are frustrating for the patient and physician alike," said Mayo Clinic urogynecologist Dr. Paul Pettit. "With the new test, the implant lead is used during the screening and implant stages. Consequently, patients who stand to benefit from InterStim Therapy are more accurately diagnosed."
As many as 20 million Americans suffer from bladder control problems, and the vast majority —about 85 percent —are women between the ages of 30 and 59. For tens of thousands of patients, firstline treatments such as medication, biofeedback and pelvic floor exercises fail to relieve the symptoms adequately. Before the introduction of InterStim Therapy in the late 1990s, these patients’ options were limited mainly to irreversible bladder surgery or a lifetime of absorbent pads or self-catheterization. Since then, more than 4,000 people worldwide have received InterStim Therapy.
The results of the retrospective clinical study, which involved five centers around the world, indicated that the new screening test was successful in 95 percent of patients (76 of the 80 patients). Data were collected from 80 urinary patients, including 14 males (17.5 percent) and 66 females (82.5 percent). The average age was 52, with ages ranging from 19 to 85 years old.
All 80 patients underwent the new test stimulation process, and 95 percent were reported to have had a positive screening result. Moreover, 91 percent of patients (73 out of 80) went on to receive the neurostimulator. Four percent (three patients) had not received a neurostimulator by the time the data was gathered, and 5 percent (four patients) were reported to have had unsuccessful test results at staged screening and were not implanted with a neurostimulator.
Adverse events were documented, whether therapy related or not, during test stimulation, during implant and after implant. Seventy-five events were reported. The most common, reported in 25 patients, was technical or device problem; infection was reported in four patients.
Medtronic’s InterStim Therapy for Urinary Control delivers mild electrical impulses to the sacral nerves with an implantable medical device akin to a cardiac pacemaker. The sacral nerves, located in the lower back, influence bladder function. InterStim Therapy first received FDA approval in September 1997 for the treatment of urinary urge incontinence. In April 1999, it was approved to treat significant symptoms of urgency-frequency and nonobstructive urinary retention.
Additional information on InterStim Therapy can be obtained by calling 800-664-5111, extension 2000, or by visiting www.interstim.com. Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease.
The FDA’s approval is based on the results of a multicenter clinical study, which demonstrated that the new approach to screening prospective patients adds a high predictive value, accurately revealing InterStim Therapy to be a viable treatment option for patients who previously were not considered candidates due to earlier inconclusive test results. The newly approved test uses a surgically placed lead —a thin, insulated wire with electrodes at one end —that can remain implanted if the test result is positive. Patients who experience a clinically significant reduction in symptoms during the screening trial may choose to proceed with the treatment.
The new screening test is approved for use with patients who had inconclusive results following testing with the earlier percutaneous testing technique. InterStim Therapy is indicated for refractory cases of urinary urge incontinence, significant symptoms of urgency frequency and nonobstructive urinary retention.
In the past, many patients have had inconclusive results following testing with a percutaneously placed, temporary test-stimulation lead. Because of the way it is placed, the percutaneous lead can move, yielding false negatives or inconclusive results. More recently, clinical researchers have determined that the percutaneous lead used in earlier screenings could move after placement and may yield false negatives or inconclusive results.
"Inconclusive test results, which often occur due to lead migration, are frustrating for the patient and physician alike," said Mayo Clinic urogynecologist Dr. Paul Pettit. "With the new test, the implant lead is used during the screening and implant stages. Consequently, patients who stand to benefit from InterStim Therapy are more accurately diagnosed."
As many as 20 million Americans suffer from bladder control problems, and the vast majority —about 85 percent —are women between the ages of 30 and 59. For tens of thousands of patients, firstline treatments such as medication, biofeedback and pelvic floor exercises fail to relieve the symptoms adequately. Before the introduction of InterStim Therapy in the late 1990s, these patients’ options were limited mainly to irreversible bladder surgery or a lifetime of absorbent pads or self-catheterization. Since then, more than 4,000 people worldwide have received InterStim Therapy.
The results of the retrospective clinical study, which involved five centers around the world, indicated that the new screening test was successful in 95 percent of patients (76 of the 80 patients). Data were collected from 80 urinary patients, including 14 males (17.5 percent) and 66 females (82.5 percent). The average age was 52, with ages ranging from 19 to 85 years old.
All 80 patients underwent the new test stimulation process, and 95 percent were reported to have had a positive screening result. Moreover, 91 percent of patients (73 out of 80) went on to receive the neurostimulator. Four percent (three patients) had not received a neurostimulator by the time the data was gathered, and 5 percent (four patients) were reported to have had unsuccessful test results at staged screening and were not implanted with a neurostimulator.
Adverse events were documented, whether therapy related or not, during test stimulation, during implant and after implant. Seventy-five events were reported. The most common, reported in 25 patients, was technical or device problem; infection was reported in four patients.
Medtronic’s InterStim Therapy for Urinary Control delivers mild electrical impulses to the sacral nerves with an implantable medical device akin to a cardiac pacemaker. The sacral nerves, located in the lower back, influence bladder function. InterStim Therapy first received FDA approval in September 1997 for the treatment of urinary urge incontinence. In April 1999, it was approved to treat significant symptoms of urgency-frequency and nonobstructive urinary retention.
Additional information on InterStim Therapy can be obtained by calling 800-664-5111, extension 2000, or by visiting www.interstim.com. Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease.
Comment