Musculoskeletal News Roundup 6-Oct-17

October 6, 2017 | Blake Mossy

REGULATORY

ChoiceSpine received 510(k) clearance from the FDA for its HAWKEYE Ti, a 3D printed titanium vertebral body replacement (VBR) device, designed to stabilize and fuse the vertebral column with elegantly simple implants in a variety of shapes and sizes. The portfolio contains small and large footprints that range in size from 10 to 50 mm in height with either 0° or 6° lordosis.

DiscGenics received approval from the FDA for its Investigational New Drug Application for a clinical study of its cell therapy product candidate from the treatment of degenerative disc disease (DDD). IDCT is a homologous, allogeneic, injectable cell therapy that utilizes proprietary Discogenic Cells to offer a non-surgical, potentially regenerative solution for the treatment of patients with mild to moderate DDD.

Intellijoint Surgical received CE Mark approval for its intellijoint HIP, a 3D mini-optical navigation system that aims to provide surgeons with precise measurements for cup position, leg length and offset for Total Hip Arthroplasty (THA). The system requires no pre-operative or intra-operative imaging; the system can be used with any implant manufacturer. Intellijoint HIP is available for both an anterior approach as well as lateral and posterior approaches, regardless of incision size.

Nexxt Spine received 510(k) clearance for its NEXXT MATRIXX 3D-printed interbody and vertebral body replacement devices.  The implants are comprised of the company’s proprietary, residue-free, surface technology with an open, varied porosity and titanium architecture to exhibit more surface area for bone apposition and more open pore volume than conventional spinal implants.

OrthAlign received CE Mark Approval from the FDA for its DAA HipAlign Direct Anterior Approach Total Hip and UniAlign Unicompartmental Knee Arthroplasty. The system does not require any pre-operative imaging or intraoperative fluoroscopy, and aims to provide clinically relevant positioning for cup placement and leg length measurement.

Spineology received 510(k) clearance from the FDA for its Elite Expandable Interbody Fusion System, an implant that is inserted into the lumbar disc space at a contracted minimum height and, once in position, is expanded to restore anatomic disc height, provide anterior column support, and aims to indirectly decompress.

PRODUCT INTRODUCTION & UPDATE

4WEB Medical launched its Anterior Spine Truss, a 3D-printed interbody fusion system for use in anterior lumbar spine procedures.  The system received expanded clearance which includes an indication for allogenic bone graft in addition to autograft.

Vivorte launched its FORTERA and REGENTO bone graft products. FORTERE is comprised of synthetic calcium phosphate cement and designed to be capable of controlled delivery through a 16-gauge cannula in a sterile, single-use kit. REGENTO is a resorbable, particulate B-TCP bone void filler with macroporosity to promote protein deposition and cell attachment.

Zimmer Biomet launched its Avenue T TLIF Cage, a posterior lumbar cage technology. The system incorporated VerteBRIDGE plating, which aims to facilitate simplified cage insertion and zero-profile, intradiscal fixation through a direct, minimally invasive surgical (MIS) approach.  Avenue T is indicated for intervertebral body fusion for the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease.

CLINICAL                                                               

OMNIlife science announced the completion of 17,000 total knee replacements worldwide using its OMNIBotics robotic platform. The system aims to optimize implant placement using its proprietary ART software which plans patient specific procedures using intra-operative 3D modeling, eliminating the need for preoperative CT scans or x-rays.

 APPOINTMENTS

Alphatec announced that Patrick Miles has been appointed as Executive Chairman and Quentin Blackford as a member of the Board, effective today.  Miles will lead the organization, and Terry Rich, Alphatec‘s Chief Executive Officer, will continue in his role, reporting to Miles. In conjunction with these appointments, Miles and Blackford are personally investing in Alphatec common stock in an aggregate amount in excess of $3.5 million. Miles brings a wealth of orthopedics and innovation expertise, with over 25 years of industry experience, and as a named inventor on close to 100 industry patents. Blackford joins the Alphatec Board of Directors with 17 years of experience in the medical device industry.  He is currently Executive Vice President and Chief Financial Officer of DexCom, Inc. Prior to joining Dexcom, Blackford was Executive Vice President, Chief Financial Officer, Head of Strategy and Corporate Integrity for NuVasive.