Medtronic plc today announced the U.S. launch of Kyphon Assist™ Directional Cannula for use with its balloon kyphoplasty (BKP) products to treat vertebral compression fractures due to osteoporosis, cancer or benign lesions. This innovative new device allows physicians greater control when inflating the bone tamp while also increasing height restoration capability compared to a traditional balloon kyphoplasty cannula¹.

The Kyphon Assist™ Directional Cannula is compatible across the Medtronic portfolio of balloon kyphoplasty products, including the Kyphon Xpander™ II Inflatable Bone Tamps. It provides the following benefits¹:

• Allows for directional control of Inflatable Bone Tamps during a balloon kyphoplasty procedure
• Additional height restoration in a vertebral body
• Ability to inflate away from lateral wall and endplate defects
• Can be exchanged with existing access tools when needed

“Kyphon Assist allows me to directionally inflate my balloon tamp and decide the force and direction of pressure,” said Dr. Thomas G. Andreshak, orthopedic surgeon at St Luke’s Hospital in Maumee, Ohio. “This allows me to obtain the best reduction of the endplates, attempt to maximize height restoration, correction of kyphosis with caution while protecting the lateral, anterior, and posterior walls of the vertebral body.”

Vertebral compression fractures (VCFs) are the most common osteoporotic fractures affecting 1.4 million people worldwide.² According to the National Osteoporosis Foundation, about 54 million Americans have osteoporosis or low bone mass that puts them at increased risk for a fracture. Breaking a bone is a serious complication of osteoporosis, especially with older patients. Osteoporotic bone breaks are most likely to occur in the hip, spine or wrist.³

A recent study of patients with osteoporotic VCFs treated with a directional balloon technique(n=49) versus traditional nondirectional balloon technique(n=51) reported significantly early and immediate outcome improvement in Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and Roland Morris Disability Questionnaire (RMDQ) scores versus the nondirectional technique at 3 days.⁴ The study also reported immediate and sustained kyphotic angle correction post-surgery. A lower procedure-related extravasation rate was seen with the directional balloon group as 4 of 49 subjects (8.2%) having bone cement leakage versus 12 of 51 subjects (23.5%), p-value 0.036 with the traditional nondirectional balloon technique.⁴

“We are excited to offer a new option when it comes to treating osteoporotic patients that allow flexibility and more control with our existing balloon kyphoplasty products,” said Anu Codaty, vice president and general manager of the Interventional Therapies business, which is part of the Restorative Therapies Group at Medtronic. “We are committed to continuously innovating in the vertebral augmentation space. Kyphon Assist will expand the capabilities of our existing Inflatable Bone Tamp Technology and empower physicians in their pursuit of delivering the best clinical solutions to their patients.”

Faced with COVID-19 and recommended treatment and state guidelines related to elective procedures, we encourage clinicians to continue working with their national and local health departments for guidance applicable to their practice to help them make an informed treatment decision on what is appropriate and applicable to their state.

References

• Medtronic Data on File. 2020.
•  Boonen S, et al. J Bone Miner Res. 2011;26(7):1627-1637.
•  National Osteoporosis Foundation Website. www.nof.org
•  Utilization of the directional balloon technique to improve the effectiveness of percutaneous kyphoplasty. Pu Wang, MD, Jin Li, MD, Zukun Song, MD, Zhan Peng, MD, Guangye Wang, MD, PhD. Medicine (Baltimore). 2019 May; 98(19): e15272