Stryker’s AVAflex Vertebral Balloon System Receives FDA 510(k) Clearance – OrthoSpineNews

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Kalamazoo, Michigan, USA March 7, 2017 Stryker announced today that its AVAflex Balloon System has received FDA 510(k) clearance and is, for the first time, available with Strykers market-leading bone cements and implants and the AutoPlex Mixing and Delivery System.

Doctors who perform vertebral augmentations are committed to the health and wellness of their patients, and Stryker is committed to empowering those doctors to provide the best possible care, said Chad Ludwig, marketing director at Stryker Instruments. The AVAflex Balloon System enables doctors to achieve bipedicular results with a unipedicular approach to vertebral augmentation.

The AVAflex and AutoPlex systems are used in the treatment of vertebral compression fractures (VCF), which affect an estimated 750,000 Americans each year. VCF patients can suffer from extreme pain and are at an increased risk for serious health problems. Vertebral augmentation, including the use of a balloon system, has been shown to provide patients with significant pain relief and dramatically reduce mortality rates.,

The AVAflex curved balloon systems new 11-gauge size allows surgeons to achieve with one insertion and a smaller needle what had previously required two insertions, making procedures less invasive and potentially reducing the risk of patient trauma. Using a minimally invasive technique, physicians can successfully create a midline cavity for targeted cement placement by accessing one pedicle.

AVAflex is now available with Strykers bone cements and implants and the AutoPlex Mixer and Delivery System, an easy-to-use bone cement mixing and delivery system. The AutoPlex system provides consistent and thorough blending of components, helping eliminate human error and variability.

Stryker has furthered its mission of making health care better for physicians, hospital staff and patients with the addition of the AVAflex portfolio, which it acquired from Becton Dickinson in 2016. Stryker provides the most complete and least invasive portfolio of vertebral compression fracture treatment options.

With an unrivaled collection of balloon catheters and augmentation options, cements, automated mixers and directional delivery systems, Stryker enables care providers to tailor their approach for the treatment of vertebral compression fractures. Stryker is now the exclusive provider of automatic mixing and delivery systems and 11-gauge curved balloons.

About Stryker

Stryker is one of the worlds leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information atwww.stryker.com.

Josh Sandberg has been an executive search consultant focused exclusively on orthopedic and spine start-ups since 2004. He has had a tremendous impact in helping his clients avoid costly hiring mistakes by his deep industry knowledge and network. In 2010, Josh co-founded Ortho Spine Companies, which is the parent company of Ortho Spine Distributors (OSD), Surg.io and Ortho Sales Partners (OSP). OSD a searchable database that helps ease the frustration of finding orthopedic distributors throughout the country. Surg.io is the ultimate distributor toolkit that offers distributors the tools necessary to build the foundation of a scalable and highly functioning sales organization. OSP is an end-to-end solution that helps companies approach the Global Market in a cost efficient way. Our team has hundreds of years of experience and can help you navigate the many challenges present in bringing new technologies to the market.

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Stryker's AVAflex Vertebral Balloon System Receives FDA 510(k) Clearance - OrthoSpineNews