From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention.
1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant
Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally mature. It is supposed to be used with spinal fixation systems like Xtant Medical’s Spider Cervical Plating and Certex Spinal Fixation Systems.
2. Life Spine touts first use of TiBow spacer
Life Spine has announced the first clinical use of its TiBow MIS TLIF Expandable Spacer System with Osseo Loc Surface Technology in an Aug. 8 press release. TiBow is designed for in-situ expansion for increased endplate coverage and stability for minimally invasive TLIF and oblique approaches. It gives the surgeon the ability to restore sagittal alignment.
3. Cardiac Science inks deal to supply AEDs to Philadelphia schools
Cardiac Science announced in an Aug. 8 press release that it has reached a deal with the School District of Philadelphia to make automated external defibrillators (AEDs) available in all 220 Philadelphia schools. Philadelphia’s high schools and middle schools already have the Cardiac Science Powerheart G3 and G5 AEDs in place and the elementary schools are set to receive the company’s Powerheart G5 units.
4. ApiFix wins nod in Australia
ApiFix has received TGA certification through its Orthotech Pty. distributor to market the ApiFix system in Australia, according to an Aug. 8 press release. The ApiFix system is designed to treat and correct adolescent idiopathic scoliosis (AIS) using a minimally-invasive surgical approach. The system is a non-fusion spinal implant system that is designed to improve the quality of life of patients who have to have scoliosis surgery.
5. Pentax Medical launches slim linear ultrasound
Pentax Medical announced in an Aug. 9 press release that it has launched its new Slim Linear Ultrasound Endoscope in the U.S. The endoscope features a smaller insertion tube, a smaller distal end and a shorter bending section to help endoscopies see and reach hard-to-access anatomy.
6. Hip Innovation launches clinical trial of novel hip replacement system
Hip Innovation Technology has started its clinical trial to evaluate the effectiveness and safety of the HRS lead hip replacement system, according to an Aug. 9 press release. The clinical study will include 100-120 patients who are scheduled to receive a total hip arthroplasty. The company plans to test effectiveness using clinical radiologic, radiostereometric and patient-reported outcomes. It will measure safety through collecting device-related adverse events. They will also assess the quality of life of each patient.
7. Varian Medical inks distribution deal with Bionix radiation therapy
Varian medical Systems announced in an Aug. 9 press release that it has entered an agreement with Bionix Radiation Therapy to distribute the Bionix brachytherapy applicators in North America. Varian has agreed to market the Bionix Esophageal Application (E-App) and the Anorectal Applicator (AR-1). E-App is a disposable brachytherapy applicator that is designed to treat upper GI cancers. It has five independently operated balloons that help maintain the central position of source catheters in straight and curved anatomy. AR-1 is a disposable brachytherapy applicator that is designed to treat anal and rectal cancers. It allows for exophytic tumors to press closer to a source catheter to deliver a very high dose to the tumor while keeping healthy tissues safe.
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