Medtronic Partners with Merit Medical to Launch Kyphon KyphoFlex Steerable Balloon Catheter for Vertebral Compression Fractures

Jun 21, 2024 22:15 CST Updated 22:15

Merit Medical

Disposable Medical Device Manufacturer

Medtronic

Chronic Disease Medical Device and Therapy Developer

Medtronic Announces Collaboration withMerit MedicalReach a cooperation agreement to introduce the steerable vertebral balloon catheter---Kyphon KyphoFlex，For the treatment of vertebral compression fractures (VCF).

According to the agreement, Medtronic is responsible forKyphon KyphoFlexAll sales, marketing, and distribution.Merit MedicalWill be responsible forKyphon KyphoFlexManufacturing, quality and safety control, regulatory activities, and lifecycle management.

Executive Evaluation

"We are delighted to partner with Merit Medical as we aim to bring more options and flexibility to our interventional product portfolio."

--- David Carr, Vice President and General Manager of Medtronic's Neuromodulation Business Pain Therapies Division, stated

"We thank Medtronic forMerit Medical"Confidence in technology. As we continue to provide the ARCADIA Steerable product portfolio to our physician customers and their patients, this latest effort will help deliver innovative steerable therapies, thereby improving the lives of more patients."

---Joe Wright, President of Merit Medical

“Merit MedicalWe have always sought to build long-term relationships with our customers, and our partnership with Medtronic dates back many years.We are pleased to leverage our operational expertise to provide them with superior technology.”

---Mike Blackham, Executive Vice President and OEM of Merit Medical

Vertebral compression fractures are the most common type of osteoporotic fracture, affecting 1.4 million people worldwide. According to the National Osteoporosis Foundation, approximately 54 million Americans have osteoporosis or low bone mass, putting them at higher risk for fractures. Fractures are a serious complication of osteoporosis, particularly in elderly patients.

Percutaneous Kyphoplasty (PKP) uses an orthopedic balloon to restore certain vertebral height and correct deformities caused by osteoporosis, cancer, or benign lesions.Vertebral Compression FractureAngular deformity. A small balloon is guided into the vertebral body through a catheter. The balloon is then carefully inflated to lift the collapsed vertebra. Once the balloon is deflated and removed, the resulting cavity can control the deposition of bone cement, which helps form an internal cast and stabilize the fracture.

In this field, Medtronic is the industry leader, having acquired in 2007 for $3.9 billion.Kyphon. This acquisition not only perfects MedtronicThe spinal product line also captured the global spinal market share, making Medtronic the king of spine.

However, after nearly two decades of development, Medtronic's product offerings in the spinal field have become increasingly comprehensive. Yet, in some niche areas, Medtronic has also noticed its products beginning to lose competitiveness. For example,Balloon KyphoplastyIn terms of shape technology, Medtronic is currently the most advanced in this细分领域.Balloon products areKyphon Balloon Kyphoplasty。Kyphon Balloon Kyphoplasty belongs toPercutaneous Kyphoplastyin China"Bilateral School." Clinical research has shown that it is better than "SingleLateral Branch"Better."

Research Results: Unilateral and Bilateral BalloonsPercutaneous KyphoplastyAll evaluated features were statistically significant. The lift generated by the bilateral approach was 105% greater than that of the unilateral approach (102.66 lbs vs. 49.99 lbs). The contact area for the bilateral method was 279% larger compared to the unilateral method (1.34 in² vs. 0.48 in²). The stress applied by the bilateral approach was 26% less than that of the unilateral approach (77.97 psi vs. 105.00 psi).

Although the Kyphon Balloon Kyphoplasty study data appears promising, it does not address the issue of the location and distribution of balloon expansion and bone cement diffusion within the vertebral body.

Bilateral puncture makes it easier to achieve uniform distribution, but the interlocking connection of bone cement diffusion from both sides of the vertebral body to the midline area is slightly more difficult.
Unilateral puncture to establish a channel to the midline area requires control of the puncture angle.，Direction of the pedicle，However, the diffusion of bone cement on both sides is slightly inferior to that in the midline area.

Therefore, innovators in the industry began to develop new technologies to address this clinical issue, with flexible vertebral augmenters and balloons becoming a solution-oriented approach.Therefore, like ShiCompanies such as Saik and Kailite are developing this type of product, and some companies have launched products with angled bends.Vertebroplasty Device、Balloon.

Medtronic believes that this fixed-angle vertebral augmenter and balloon cannot achieve optimal positioning, thereby compromising the treatment outcome. To address this, Medtronic has collaboratedMerit MediCAL Develops a New Type of Freely Adjustable Kyphoplasty Balloon Catheter---Kyphon KyphoFlex, thereby makingOnce entering the vertebra, the track can be modified.Trace, to achieve optimal positioning and enhance treatment efficacy.

Kyphon KyphoFlexAimed at achieving controlled, precise, and targeted cavity creation in vertebral augmentation surgeries. The "unilateral" solution will complement Medtronic's current"DoubleSide”Pedicle Balloon Kyphoplasty Solution Offers Clinicians More Flexibility and Options.

Merit Medical

Merit Medical, founded in 1987, is a leading medical device manufacturing company that produces devices used in cardiac and radiological interventional procedures. Merit Medical's product line includes inflation devices and accessories, diagnostic and therapeutic catheters and guidewires, disposable pressure monitoring equipment, contrast management systems, non-vascular stents, thrombolytic catheters, syringes, and needles, among others. The company is committed to meeting the needs of cardiology and radiology experts worldwide through product innovation and high-quality manufacturing.