Medtronic's Specify SureScan
MRI surgical leads
MRI surgical leads
Medtronic’s Specify SureScan MR surgical leads get FDA nod
March 05, 2016
by Lauren Dubinsky, Senior Reporter
Medtronic announced on Thursday that it received FDA approval for its Specify SureScan MRI surgical leads, which are used with the company’s implanted spinal cord stimulation (SCS) systems for patients suffering with chronic pain.
"More than 70 percent of MRIs performed are of the chest, spine, torso, pelvis, heart, or breast. This means that unless someone has a full-body MRI compatible SCS system, they cannot safely undergo these MRIs, which could have adverse health consequences," Dr. Marshall Stanton, senior vice president and president of Medtronic Pain Therapies, told HCB News.
Medtronic claims that it is the only vendor that offers a full portfolio of SCS systems that are approved by the FDA for full-body MR exams. Physicians can now select the SCS system that is ideal for their patients, whether they need a rechargeable or non-rechargeable neurotransmitter or if the lead is for percutaneous or surgical use.
According to a recent study published in the journal Spine, 82 percent of patients implanted with a SCS are expected to require an MR within five years of receiving the implant. Some of those patients have not been able to undergo MR scans because the electromagnetic field can lead to injury or damage the device.
They have the alternative of undergoing a CT scan, but that modality is not as effective as MR at evaluating soft tissue. In some instances, the patients had the SCS system taken out before the MR exam.
A Global Burden of Disease 2010 study found that low back pain is the single leading cause of disability around the world. In addition, back pain is also the second most common reason that people visit the doctor’s office, according to the Chiropractic Association.
For some of those patients, medication or physical therapy may alleviate the problem, but others might need surgery, nerve blocks or medical devices including SCS systems or drug pumps.
The SCS systems are implanted under that patient’s skin and work by transmitting electrical pulses to an area near the spine in order to disrupt pain signals traveling between the spinal cord and brain. A study published in the journal Pain found that SCS systems provide patients with effective pain relief and improved function.
"More than 70 percent of MRIs performed are of the chest, spine, torso, pelvis, heart, or breast. This means that unless someone has a full-body MRI compatible SCS system, they cannot safely undergo these MRIs, which could have adverse health consequences," Dr. Marshall Stanton, senior vice president and president of Medtronic Pain Therapies, told HCB News.
Medtronic claims that it is the only vendor that offers a full portfolio of SCS systems that are approved by the FDA for full-body MR exams. Physicians can now select the SCS system that is ideal for their patients, whether they need a rechargeable or non-rechargeable neurotransmitter or if the lead is for percutaneous or surgical use.
According to a recent study published in the journal Spine, 82 percent of patients implanted with a SCS are expected to require an MR within five years of receiving the implant. Some of those patients have not been able to undergo MR scans because the electromagnetic field can lead to injury or damage the device.
They have the alternative of undergoing a CT scan, but that modality is not as effective as MR at evaluating soft tissue. In some instances, the patients had the SCS system taken out before the MR exam.
A Global Burden of Disease 2010 study found that low back pain is the single leading cause of disability around the world. In addition, back pain is also the second most common reason that people visit the doctor’s office, according to the Chiropractic Association.
For some of those patients, medication or physical therapy may alleviate the problem, but others might need surgery, nerve blocks or medical devices including SCS systems or drug pumps.
The SCS systems are implanted under that patient’s skin and work by transmitting electrical pulses to an area near the spine in order to disrupt pain signals traveling between the spinal cord and brain. A study published in the journal Pain found that SCS systems provide patients with effective pain relief and improved function.