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Pinnacle Spine Files with FDA for 510(k) Clearance to Market their InFill® Lateral Fusion System with PEEK-OPTIMA™ HA Enhanced Polymer

Posted On November 1, 2017 By OrthoSpineNews In Regulatory, Spine /  

DALLAS & THORNTON CLEVELEYS, UK (PRWEB) OCTOBER 31, 2017

Pinnacle Spine Group, LLC, the pioneer of in situ graft delivery in spinal fusion, today announced it has filed an application with the Food and Drug Administration (FDA) seeking 510(k) clearance to market its lateral InFill® Lumbar Fusion Systems with PEEK-OPTIMA HA Enhanced polymer from Invibio Biomaterial Solutions (Invibio).

Pinnacle Spine Group pioneered and commercialized the novel concept of delivering bone graft material in situ into an implanted device in order to fill the biologic void that remains with other spinal fusion systems. Invibio’s PEEK-OPTIMA HA Enhanced polymer is an implantable biomaterial grade that combines two clinically proven advanced biomaterials for enhanced bone apposition: PEEK-OPTIMA and Hydroxyapatite (HA), a well-known osteoconductive material. PEEK-OPTIMA HA Enhanced encourages bone on-growth on all surfaces of a device while providing the strength, versatility and performance advantages of its proven predecessor, PEEK-OPTIMA Natural.

“We are excited about the possibility of combining the proven clinical benefits of Invibio’s PEEK-OPTIMA HA Enhanced with the benefits of Pinnacle Spine’s patented InFill technology,” said Zach Sowell, President of Pinnacle Spine Group. “Once cleared we believe the combination of these two technologies will provide surgeons with an ideal solution for improved outcomes in lumbar fusion, one of the more challenging approaches to achieve successful fusion.”

“Pinnacle Spine Group and Invibio share a passion for trying to improve the effectiveness of bone growth in the graft space,” said John Devine Medical Business Director, Invibio Biomaterial Solutions. “The combination of Pinnacle’s technology with our own pioneering materials feels like an obvious collaboration.”

Invibio´s PEEK-OPTIMA HA Enhanced biomaterial offers all the clinical advantages of PEEK-OPTIMA Natural including a modulus similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear fusion assessment. Developed by Invibio, a leading provider of biomaterial solutions, this innovative high performance polymer for spinal fusion implants eliminates the extra processing time and expense of alternative bone on-growth technologies, such as coatings. Implant devices made of the novel PEEK-OPTIMA HA Enhanced have already been cleared by regulatory bodies in both the US (FDA 510(k) clearance) and Europe (CE mark approval).

Pinnacle Spine Group was recently granted a new patent related to the delivery of graft material to fill the internal chamber(s) of a spinal fusion device, while allowing for graft material to be in flush contact with the endplate surfaces of the adjacent vertebral bodies. In addition, Pinnacle was recently awarded a new patent related to the architecture of the lateral implant. These latest patents follow the receipt of three earlier U.S. patents covering Pinnacle Spine’s innovative InFill® fusion technology. The company also owns several non-U.S. applications, including applications in Australia, Canada and Europe.

Pinnacle Spine’s InFill® Fusion Systems include an array of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting area, and compatibility with the InFill® graft delivery system. The backbone of the technology is predicated on controlled and precise in-situ placement of bone graft material directly into the implanted device, to achieve maximum contact with the adjacent vertebral endplates.

About Pinnacle Spine Group, LLC

Based in Dallas, Texas, Pinnacle Spine Group, LLC is a privately held medical device company that develops and markets innovative technologies to improve spinal fusion procedures. The Company’s family of FDA-510(k) cleared InFill® Fusion systems provides for superior endplate-to-endplate contact of bone graft material and a complete fill of the disc space, achieved by post-filling the implants after they have been delivered into a targeted intervertebral disc space.

About Invibio Biomaterial Solutions

Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide. Further information is available on Invibio´s new website: https://invibio.com
INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

Contact:
Mr. Zach Sowell, President
Pinnacle Spine Group, LLC
214-466-1428

Contacts
Invibio Biomaterial Solutions
Barbara Pasciak, Marketing Communications Manager
barbara.pasciak(at)invibio(dot)com, Phone +1 484-342-6041

Victrex media contact
Beate Sauer, PR & Marketing Communications Manager
bsauer(at)victrex(dot)com, Phone +49 61 92 / 96 49 19

Victrex: Group media or Investor Relations enquiries
Andrew Hanson, Director of Investor Relations & Corporate Communications
ahanson(at)victrex(dot)com, Phone +44 12538 98121

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ECA Medical Instruments Launches Cervical-One™ Sterile-Packed, Disposable Instrument Kit for One & Two-Level Fusions

Posted On November 1, 2017 By OrthoSpineNews In Spine, Top Stories /  

November 1, 2017

Thousand Oaks, CA.—ECA Medical Instruments, the leading designer and manufacturer of single-procedure torque-limiting instruments and surgery-ready procedural kits for the medical industry and surgeons worldwide, has launched the Cervical-One™ single-procedure instrument set for use in one and two-level cervical spine implant procedures.  The novel instrument set is available for tailoring and branding by spine implant OEMs for securing both plates and screws and interbodies commonly used to treat spine degeneration and deformity cases.

ECA markets and sells its single-use instruments and complete procedural kits to medical device OEMs for private labeling and branding, saving them significant R&D investment and accelerating time to market for new product introduction or legacy product refresh.  Tailored to implant manufacturer specifications the Cervical-One™ kits can be branded in different colors, handle shapes and sizes. The instrument sets are ready for rapid adoption across the marketplace to reduce operating cost, eliminate instrument cleaning and re-sterilization, improve patient safety and provide perfect fixation of implants while reducing risk of surgical site infection.

“Cervical-One™ offers spine implant OEMs essentially an off-the-shelf and surgery ready solution that provides them differentiated instrumentation to both clinically and economically meet the growing demand for cervical spine degeneration repair,” said Lane Hale, president and CEO of ECA Medical Instruments. “The simplicity of design and modular instrument approach allows for easy branding and modification to meet surgeon needs for implant fixation, navigation, procedural stack up and OR efficiency gains,” he said.  

ECA is marketing the fully disposable instrument kits in three configurations: 1) instrument set for anterior cervical plate and screw fixation, 2) interbody implant fixation kit, and 3) a combined anterior cervical discectomy fusion (ACDF) kit combining instrumentation.

The kits include the full complement of instruments needed by surgeons and OR teams including precision torque-limiters and drivers.  All the instruments use state of the art medical grade polymers for strength and durability, are validated and packaged in sterile-pack fully recyclable trays.

An early adopter of the Cervical-One™ instrument kit is Zavation Medical, Jackson, MS.   Zavation is collaborating with ECA to develop a family of kits for stand-alone and combined fixation of one and two-level plating and also interbody cages (artificial discs). Zavation expects to launch their new SteriCerv™ line of products in early 2018.  Both Zavation and ECA demonstrated the new instrument kits to neurosurgeons and orthopaedic surgeons at the North American Spine Society (NASS) 2017 conference last week in Orlando.

“Single-use instrument kits coupled with sterile packed implants are clearly the way of the future for high volume and relatively low complexity spine surgeries in both the hospital and outpatient setting,” Hale said. “We’re excited to partner with both large and small/medium enterprise OEMs across the spine industry and bring these new instrument kits to market.”

Single-procedure instruments and procedural kits are providing surgeons and patients alike with a pristine set of ready for surgery instruments for securing a wide range of medical device implants. Sustained benefits include elimination of reprocessing costs, improved OR efficiency, reduced risk of surgical site infection and reduction in hospital and ASC inventory management.

ECA is a one stop shop OEM instrument company providing implant firms with complete product design and development, product and packaging validations, CE Mark and dock to stock operations. This reduces OEM costs and accelerates time to market.

About ECA Medical Instruments

ECA Medical Instruments®, a LongueVue Capital Partners company, was founded in 1979 and located in Thousand Oaks, CA.  ECA is the industry leader in single-procedure torque-limiting instruments and surgical fixation kits. The company has manufactured and delivered over 35 million precision torque instruments to the world’s leading producers of CRM, neuromodulation, cardiovascular and orthopaedic and spine implants resulting in over 500 million precision surgical actuations. Every 20 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA is an ISO 13485, CE Mark certified and FDA registered company and was named Business of the Year 2017 by LivaNova. www.ecamedical.com

 

Media Contact: James Schultz   

Phone: +1 805-990-6177

Email: jschultz@ecamedical.com

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