KPA15: Medtronic Kyphon KyphoFlex Unipedicular Steerable Balloon Catheter Kit w/QL 1455 Inflation Device, 10G, 15mm

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| Price: | $599.00 per kit |
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Additional Details
Medtronic KPA15 Kyphon KyphoFlex Unipedicular Balloon Kit, 15 mm
Medtronic KPA15 Kyphon KyphoFlex Unipedicular Balloon Kit is designed for vertebral augmentation procedures using steerable osteotome and balloon technology for targeted cavity creation within the vertebral body. The 15 mm system supports unipedicular access during balloon kyphoplasty for treatment of applicable vertebral compression fractures.
Product Code: KPA15
- Manufacturer: Medtronic
- Product Name: Kyphon KyphoFlex Unipedicular Balloon Kit
- Product Family: Kyphon KyphoFlex
- Device Type: Vertebral augmentation balloon kit
- Balloon Length: 15 mm
- Access Configuration: Unipedicular
- Clinical Application: Vertebral body cavity creation and fracture reduction during vertebral augmentation
- Procedure Type: Balloon kyphoplasty
- Anatomical Application: Vertebral body
- Specialty: Orthopedic Surgery and Neurosurgery
Contents
- Bevel tip introducer
- Diamond tip introducer
- Biopsy device
- PowerCURVE navigating osteotome
- KyphoFlex steerable balloon
- Inflation syringe: Atrion QL 1455 REF 96508
- Locking delivery cannula
- Elbow adapter
- 20 mL VacLok syringe
Features
- Navigating osteotome enables trajectory modification after crossing the pedicle-body junction
- High-pressure, low-compliance steerable balloon supports controlled vertebral cavity creation
- Unipedicular configuration supports treatment through a single pedicle access path
- Resheathing tool locks into the handle for procedural use
- Designed for targeted cavity creation during vertebral augmentation
Sterilization
- Device Packaged as Sterile: Yes
- Requires Sterilization Prior to Use: No
- Single-Use, Disposable
AccessGUDID Info
- FDA Product Code: HRX
- FDA Product Code Name: Arthroscope
- GMDN Term Code: 47021
- GMDN Term Name: Inflatable bone tamp
- GMDN Term Description: A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
Manufacturer
Medtronic’s former Minimally Invasive Therapies Group (MITG), now part of the Surgical and Endoscopy Operating Units within the Medical Surgical Portfolio, focuses on advanced technologies that support minimally invasive procedures across general, bariatric, colorectal, and thoracic surgery. The portfolio includes a wide range of surgical stapling systems like the Signia and Endo GIA platforms, energy devices such as the LigaSure vessel sealing system and Valleylab electrosurgical generators, as well as a robust line of trocars, sutures, and advanced instrumentation. MITG also includes market-leading solutions in gastrointestinal diagnostics and respiratory monitoring, including the Bravo pH monitoring system and the Puritan Bennett ventilators. Medtronic’s innovations in this space aim to improve surgical precision, reduce complications, and enhance recovery through technology-driven, value-based care.
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