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Bryn Mawr Hospital medical staff surgeon treats first patient using Innovative Surgical Designs, Inc. Altum® Pedicle Osteotomy for spinal stenosis

Bryn Mawr Hospital August 9, 2018 Research News

Mark Kurd, MD, orthopaedic surgeon on the medical staff at Bryn Mawr Hospital, part of Main Line Health, treated the first patient using the Innovative Surgical Designs, Inc., Altum® Pedicle Osteotomy System. The patient was treated through a randomized clinical trial that compares the safety and effectiveness of the Altum® implant to transforaminal lumbar interbody fusion (TLIF) in patients with symptomatic, one or two level lumbar spinal stenosis (LSS) and one level grade I degenerative spondylolisthesis requiring surgical treatment.

“We are thrilled to be participating in the clinical evaluation of this new minimally invasive treatment option for patients with lumbar spinal stenosis and degenerative spondylolisthesis,” says Dr. Kurd, who serves as the study’s principal investigator. “As a leader of orthopaedic care in the region, Bryn Mawr Hospital is honored to have had the first patient treated using this innovative system.”

The Altum® Pedicle Osteotomy System contains the implants and instruments required to perform the pedicle lengthening osteotomy procedure for the treatment of lumbar spinal stenosis in the setting of degenerative spondylolisthesis. The Altum® implant is an expandable bone screw that is available in a variety of sizes (7.5 mm, 8.5 mm and 9.5 mm). Altum® instruments and implants come in a single-use disposable kit.

“We are excited and hopeful that we will be able to prove the safety and effectiveness of this new device for the treatment of patients with lumbar spinal stenosis and spondylolisthesis,” said Jonathan Rinehart, general counsel, Innovative Surgical Designs, Inc. “I have personally been very surprised at how receptive patients have been during the recruitment process. If the trial proves successful it may carve out a new market in spine for those patients who are currently delaying surgery.”

The trial is a multi-center study that will enroll 344 subjects between the ages of 40 and 80. Those who meet all eligibility criteria consent to receive randomization into either one of the following: transforaminal lumbar interbody fusion (TLIF) treatment cohort or the Altum® pedicle osteotomy treatment cohort. Following treatment, subjects are observed and evaluated for a two year period.

For more information on the trial, please visit clinicaltrials.gov/ct2/show/NCT03381677. For information about Orthopaedic Services at Main Line Health, visit mainlinehealth.org/specialties/orthopaedic-surgery.

Please note: In full disclosure, Dr. Kurd’s surgical practice partner is a stakeholder at Innovative Surgical Designs, Inc., the developers of the Altum® Pedicle Osteotomy System. Dr. Kurd does not have any personal financial interest in the technology.

About Main Line Health

Founded in 1985,Main Line Health is a not-for-profit health system serving portions of Philadelphia and its western suburbs. Main Line Health’s commitment—to deliver advanced medicine to treat and cure disease while also playing an important role in prevention and disease management as well as training physicians and other health care providers—reflects our intent to keep our community and ourselves well ahead. A team of more than 10,000 employees and 2,000 physicians care for patients throughout the Main Line Health system.

At Main Line Health’s core are four of the region’s most respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation’s recognized facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital.

Main Line Health also includes Mirmont Treatment Center for drug and alcohol recovery; Main Line Health HomeCare & Hospice, which includes skilled home health care, hospice and home infusion services; Main Line Health Centers, primary and specialty care, lab and radiology, and other outpatient services located in Broomall, Collegeville, Concordville, Exton, King of Prussia and Newtown Square; Lankenau Institute for Medical Research, a biomedical research organization; and Main Line HealthCare,one of the region’s largest multispecialty physician networks.

Main Line Health is the recipient of numerous awards for quality care and service, including System Magnet® designation, the nation’s highest distinction for nursing excellence and the Mid-Atlantic Alliance for Performance Excellence (MAAPE) Excellence Award. Main Line Health is committed to creating an environment of diversity, respect and inclusion and has proudly embraced the American Hospital Association’s #123forEquity Pledge to Act to eliminate disparities in care. We are dedicated to advancing patient-centered care, education and research to help our community stay healthy.

About Innovative Surgical Designs, Inc.

Innovative Surgical Designs, Inc. is a privately held, orthopaedic medical device company focused on developing breakthrough minimally invasive treatments for patients with lumbar spinal stenosis. Innovative Surgical Designs, Inc. developed Altum® to provide surgeons with a new treatment option to provide a minimally invasive, percutaneous direct decompression of the nerve root while still maintaining the natural elements of the spine. Altum® utilizes a revolutionary bone saw that performs an osteotomy at the base of the pedicle and then implants an expandable device to directly decompress the nerve root as an alternative to instrumented surgery.