Published on February 27th, 2015

Pain-free Technology Gives New Hope to Spinal Surgery Patients

It may take a year, but one area health network has taken a key role in what is expected to be approval of a pain management method by the Food and Drug Administration.

St. Luke’s University Health Network based in Bethlehem is halfway through a six-month clinical study that implants a neuro-stimulation device referred to as Burst into patients during spinal cord stimulation surgery.

The minimally invasive procedure is done to alleviate chronic pain that often is in a patient’s arms, legs or torso. It frequently may be associated with failed back surgery.

“Basically, we put an electrode on the spine. Normally, with this kind of surgery we stimulate nerves that are creating pain. So, patients would get a tingly sensation,” said Dr. Steven M. Falowski, a neurosurgeon at St. Luke’s who performs spinal cord surgery at the Bethlehem and Quakertown hospital locations. “With the new device, a patient gets the pain relief without the tingling or any other sensation.”

During the procedure, a small device with a Prodigy battery pack and thin wires is placed along the spinal cord. The treatment is used to halt transmission of pain signals to the brain.

Since the start of the study, Falowski said, he has implanted the new Prodigy device with the Burst therapy into five patients, and the mechanism is programmed to give them no sensation when pain occurs.

So far, those chronic pain patients have had their pain medicine cut in half or no longer have to take it. He expects to enroll five to 10 more people in the study before it wraps in a couple of months.

The neurosurgeon has been with St. Luke’s for four years and has been doing spinal surgery for 10 years. He explained that he does 150 spinal cord procedures a year. His experience is one of the biggest reasons that St. Luke’s was one of 20 hospitals selected nationwide to take part in this clinical study by medical device manufacturer St. Jude Medical Inc. of Texas.


St. Luke’s neurosurgeon Dr. Steven M. Falowski prepares to place the Prodigy neuro-stimulation unit into the spine. Falowski is one of the investigators for a clinical study using the unit to treat chronic pain, and St. Luke’s is one of 20 hospitals chosen by St. Jude Medical Inc. to participate in the study.

Falowski, who works closely with Scott Loev, director of pain medicine at St. Luke’s Spine and Pain Associates, said Loev assists with qualification of patients. This includes a series of treatments, and not everyone qualifies.

However, patients with chronic pain for years and those who have had prior back surgery are good candidates.

The Institute of Medicine of the National Academies found that about 100 million people in the U.S. suffer from chronic pain, and it costs the nation up to $635 billion annually in medical treatment and lost work and productivity.

St. Jude already has a device on the market called the Protégé that has the Burst therapy imbedded in it. It has a software program that can be upgraded to be turned on to give patients the Burst therapy if the FDA approves it.

Falowski said he has implanted the Protégé into 50 patients in the last year. The Protégé gives patients a tingly sensation in place of pain. Those people that receive the tingling also had their pain meds cut in half or eliminated totally.

The new Prodigy device that gives Burst therapy “has been on the [international] market a while. It has received… approval in Europe, but now the U.S. has to get onboard,” Falowski said. “Approval could take a year, and we could have as many as 200 patients waiting to get reprogrammed by then.”

If the FDA approves it, it could take hospitals three to six months to get a supply of this device, said the neurosurgeon, adding that since St. Luke’s is participating in the study, it will be one of the first hospitals to have access to the device.

Jonathan Bilbow, clinical technician for St. Jude Medical, is in the operating room with Falowski when he implants the chronic pain management device. He is there to assist the neurosurgeon in programming the device and continues to keep up with the patient following the procedure.

“This is life-changing for patients who have debilitating pain, and they can function again on a daily basis and find enjoyment out of life again,” said Bilbow, adding that this program with the device that creates tingling has been around for six or seven years but has grown significantly in the last four years. Its latest no-sensation feature has only been circulating in Europe for a year.

“We are the only company that provides this therapy, and the results are good. Patients no longer have pain, and they are not subjected to another therapy,” Bilbow said.

Falowski said that, so far, he is satisfied with the progression of the study.

“This is not a last-resort therapy. It is an in-and-out surgery that gives comfort to people who are in extreme chronic pain for a long time,” he said. “We help people with a disability get back to work. We give them back their quality of life.”

By Jennifer Troxell Woodward
January 26, 2015
Read the original Lehigh Valley Business article here.

St. Luke’s Neurosurgery in the News

The St. Luke’s University Health Network Clinical Trials Office, under the leadership of Tracy Butryn, MS, CCRP, Director of Clinical Trials and Research, and Christy Stehly, BS, Manager of Med-Surg Integrated Clinical Trials, is responsible for overall study coordination, data collection and regulatory oversight of this ground-breaking study.

“The success of this study would not have been possible without the dedication and knowledge of Dr. Falowski, a renowned expert in neurosurgery and innovative surgical techniques, as well as his relationships with leading industry supporters,” says Tracy Butryn, MS, CCRP, Director of Clinical Trials and Research, St. Luke’s University Health Network. “Additionally, the St. Luke’s centralized Clinical Trials Office has the expertise and infrastructure in place to coordinate and execute a national clinical study of this caliber, serving as the backbone of research at SLUHN.”

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