Medtronic Bone Cement Cleared for Sacroplasty

Medtronic plc has had FDA permission to market its Kyphon Xpede Bone Cement for the treatment of vertebral fractures for some time.

On March 14, 2017, the Dublin, Ireland-based company said it has now received 510(k) FDA clearance to market the cement, “for fixation of pathological fractures of the sacral (pelvic) vertebral body using sacral vertebroplasty or sacroplasty.”

Sacral Insufficiency Fractures

Sacral insufficiency fractures (SIF) are a common cause of lower back pain, especially for elderly people. Sacroplasty is a technique that “internally casts” a sacral fracture with liquid cement.

SIFs mimic the symptoms of lumbar spine pathology and are commonly missed or underdiagnosed, stated the company announcement. “Since the sacral ala is composed predominantly of cancellous bone—the first to be reduced in cases of osteoporosis and other metabolic conditions.”

The company cites data which shows incidence rates ranging from 1 to 5% in at-risk populations. According to the National Osteoporosis Foundation, about 54 million Americans have osteoporosis and low bone mass, placing them at increased risk for a fracture of any kind.

Douglas Beall, M.D., chief of Radiology Services at Clinical Radiology of Oklahoma, said, “Sacral insufficiency fractures are associated with a tremendous amount of pain and debilitation for individuals who have them. Having this new indication with Kyphon Xpede Bone Cement to use in the treatment of sacral fractures will help to address this patient population.”

The company said a recent multi-center retrospective study of 243 patients with osteoporotic SIFs treated with sacroplasty (Kortman K, et al. Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg. 2013 Sep 1;5(5):461-6.) reported “significant pain relief for patients immediately following the procedure and after one-year follow-up; authors indicated that there were no major complications or procedure related deaths. The study reported a low procedure-related complication rate with 1 of 243 subjects (0.4%) having symptomatic leakage requiring decompression.”

Jeff Cambra, general manager of Medtronic’s Interventional Pain Therapies business, which is part of the Restorative Therapies Group, said, “As the pioneers in balloon kyphoplasty for treating vertebral compression fractures, this expanded indication for Kyphon Xpede Bone Cement demonstrates our long-term commitment to continuously innovate and empower physicians to deliver the best clinical solutions to their patients.”

Balloon kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.

The bone cement is a quick-to-dough bone cement that the company says provides ease of handling and allows sufficient time for careful, minimally invasive use. When paired with the Kyphon Cement Delivery System, clinicians can minimize their radiation exposure by standing up to four feet away from the radiation source during injection, which has been measured to reduce hand radiation exposure by 70%.

Indications and Risks

The product is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e., kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

The company discloses that risks of acrylic bone cements include cement leakage which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as:

• Cardiac arrest
• Cerebrovascular accident
• Myocardial infarction
• Pulmonary embolism
• Cardiac embolism

Payer Coverage

Payer coverage for sacroplasty may vary. The company recommends providers review all payer coverage policies and/or call payers to determine coverage criteria and appropriate coding.