IRVING, TX – February 16, 2024 –Astura Medical, a leader in innovative spinal surgery technologies, is proud to announce that it has received FDA 510(k) clearance for its Dominion Expandable Corpectomy System.

Designed with patient outcomes in mind, the Dominion Expandable Corpectomy System features state-of-the-art, expandable columns with modular adjustable endplates that allow for a customizable anatomical fit, ensuring each procedure is as unique as the patient it serves. The system’s modular design and intuitive instrumentation facilitate a streamlined surgical process, offering surgeons unprecedented flexibility, precision, and safety for spinal corpectomy procedures.

“The Dominion Expandable Corpectomy System is the culmination of extensive research and innovation, designed to meet the evolving needs of spinal surgeons and their patients undergoing corpectomy procedures,” said Thomas Purcell, Co-founder and Vice President of Astura Medical. “This FDA clearance is a testament to our commitment to advancing spinal care and improving patient lives through innovative technology.”

The Dominion Expandable Corpectomy System is one of several new technologies the company is scheduled to release in 2024. Other platforms slated for launch are the Reunion Sacroiliac (SI) Joint Fusion, Masada Modular Screw System, Wicklow Anterior Access System, Olympic Sublaminar Bands, and Sirion X Expandable LLIF.

For more information about the Dominion Expandable Corpectomy System and other innovative solutions from Astura Medical, please visit our website at asturamedical.com.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high-quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

Astura Medical, a dynamic spine technology company, is excited to announce that it has received FDA 510(k) clearance for its groundbreaking Masada Modular Spinal Fixation System.

The Masada System is a versatile spinal fixation solution designed to empower surgeons and improve patient outcomes for complex spinal pathologies. It features a wide array of modular screw options with configurable tulips, offering translation, articulation, and rotation variability for enhanced surgical efficiency. Surgeons can easily adapt to individual patient anatomies using standard, extended-top, dual-head, and high-top tulip options during surgery.

The tulips are available in polyaxial, monoaxial, or fixed-angled configurations and can be connected to 5.5 or 6.0mm rods. Cortical Cancellous screws with varying thread pitch options are provided, and the system includes self-drilling guide wireless navigated, cannulated, and stylet tip configurations. These screws come in diameters ranging from 4.0 to 10.5mm and lengths from 20 to 120mm, offering precise options for different surgical needs.

Joel Gambrell, Co-founder, and CEO, commented, “The Masada system marks a significant milestone for Astura. It empowers surgeons with unprecedented precision and adaptability, ensuring the highest standard of patient care. With this innovative system, we’re setting a new standard for excellence with best-in-class implants and instruments.”

The Masada System is equipped with a Tulip Unlocker for intraoperative tulip screw unlocking. This function simplifies the final tulip removal process with low-profile standard and high-top tulip removers, enhancing surgical efficiency. The system also includes a comprehensive range of cannulated and non-cannulated screw shank drivers, available in standard, navigated, or stickfit options, providing the precision and versatility needed for complex spinal surgeries.

Astura Medical is set to introduce several new expandable technologies in the coming months, with the Masada System marking the third clearance in 2023.

Astura Medical, a leading spine technology company, is excited to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative Reunion Sacroiliac (SI) Joint Fusion System.

This advanced platform is designed for both minimally invasive lateral and posterior approaches for SI joint stabilization and fusion. It offers a wide range of instrumentation and modular screws for versatile surgical techniques.

The Reunion system enables surgeons to perform SI joint fusion through two different approaches and offers a range of modular screws with diameters of 8, 10, 12, or 14mm and lengths from 35-80mm. It also provides two screw options, a modular head with a dual lead thread or a compression style head with a compression thread.

The system includes modular screw heads with an integrated automatic locking anti-rotation feature for secure attachment to the implant screws. The screw heads come in either a Flush Mount or Variable Surface Mount screw head, depending on the desired proximal anchoring technique.

Joel Gambrell, Co-founder, and CEO, said, “Reunion is the result of years of research and a commitment to improving the quality of life for SI joint disorder patients. We’re proud to offer a solution that enhances surgical precision and patient outcomes.”

In addition to the FDA clearance for the Reunion System, Astura Medical has several new technologies awaiting approval, including an expandable corpectomy cage and expandable articular TLIF. These innovations are expected to receive clearance in the coming months, positioning Astura Medical as a leading player in the spine industry.

For more information, visit www.asturamedical.com or find us on LinkedIn.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high-quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

Astura Medical, a rapidly growing and innovative spinal device technology company, announced the full commercial release and first case with the company’s most recent expandable technology, El Capitan X Expandable Anterior Lumbar Interbody Fusion (ALIF) System. The first case was successfully completed by Jason Taub, M.D. from Dallas Neurosurgical & Spine at the Methodist Hospital for Surgery in Addison.

Building upon the foundation of the success of the company’s other integrated plate/spacer technologies and expandable interbody platforms, El Capitan X represents the first and only system to provide a complete range of expandable anatomic spacers and fixation options with infinitely adjustable expansions in height and lordosis up to 30° for a unique, patient-specific solution.

“Our goal is to always find ways to continue to optimize care with the latest, most innovative solutions for each of our patients,” said Dr. Jason Taub. “The extensive capabilities of the El Capitan X Expandable ALIF System provides an unmatched ability to deliver a truly patient-specific solution every single time.”

“The commercial launch of El Capitan X marks another major milestone for our organization, as we’re once again redefining what’s possible in terms of intraoperative flexibility and versatility for our surgeon, distributor, and hospital partners,” added Joel Gambrell, Co-founder and CEO.

Astura Medical will be highlighting El Capitan X during their next cadaveric training program on Sat., Sep. 23rd at the company’s headquarters in Irving, TX. Additionally, the company will be showcasing the El Capitan X, along with several of their newest technology platforms during the North American Spine Society (NASS) 2023 Annual Meeting event in October in Los Angeles, CA.

For more information, please visit LinkedIn or El Capitan X

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high-quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

IRVING, TX – Astura Medical, a rapidly growing and innovative spine technology company, is proud to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary Sirion X Expandable Lateral Lumbar Interbody Fusion (LLIF) System.

Sirion X has been designed to deliver an all-encompassing range of expandable anatomic spacers and fixation solutions, including the option of non-plated or two-hole implants with standard or hyperlordotic cages. The spacers feature biplanar expansion starting at 16mm anterior/posterior (A/P) to minimize retraction forces within the psoas and expanding up to 22mm A/P, as well as increasing in height by up to 5mm and up to 25º of lordosis. This allows for a controlled disc height restoration and an optimized fit while reducing the risk of iatrogenic endplate disruption.

The implant features acid-etched endplates and an integrated bone graft delivery system that delivers higher volumes of graft material and better endplate contact. The comprehensive selection of implants and related instruments has been designed to streamline the surgical process, offering surgeons the ability to confront even the most challenging circumstances through multiple techniques.

“We are thrilled to announce the approval of Sirion X, which represents a significant milestone for our surgeon designers and engineering team. Our dedication to creating patient-specific solutions has culminated in a market-leading system in terms of intraoperative flexibility and versatility,” said Joel Gambrell, Co-founder, and CEO.

Sirion X is the second expandable technology to be granted 510(k) approval by the FDA in 2023, following El Capitan X Expandable ALIF in January.

For more information, please visit Sirion X or LinkedIn.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high-quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

IRVING, TX – Astura Medical, a rapidly growing and innovative spine technology company, is proud to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary Sublaminar Bands, which will serve as a supplementary set to the Olympic Deformity Posterior Spinal Deformity System.

Building upon the technological advancements achieved with the Olympic Deformity System, Astura’s Sublaminar Bands Set provides surgeons with an alternative way to stabilize and correct spinal deformities by fastening rods and connectors.

“I’m proud of the efforts by our surgeon design partners and internal team to establish a new high-water mark for what’s possible in terms of intraoperative flexibility and versatility when sublaminar bands are utilized,” said Thomas Purcell, Co-founder, and Vice President.

The Sublaminar Bands System allows surgeons to choose between using a complete band-only technique or used in conjunction with the Olympic Deformity System to create a hybrid construct that allows for the use of Hooks, Pedicle Screws, and multiple connectors throughout the lumbar and thoracic spine, providing greater surgical precision and control. With an array of sublaminar PET bands and associated connectors, the system is designed to support the vertebral segments and ensure successful surgical outcomes that are tailored to each individual patient.

One of the features of the Sublaminar Bands System is its band tensioner, which is equipped with an integrated gauge feature. This feature enables surgeons to precisely measure the tension applied to the bands, ranging from 75 to 150N of force. This level of control and accuracy provides surgeons with greater confidence in their surgical procedures, ultimately leading to the aim of delivering more precise and successful surgeries.

The Sublaminar Bands System is the first of several supplemental systems to be added to the Olympic Deformity System this year, including Osteotomy and Direct Vertebral Rotation (DVR). The company is scheduled to introduce several new, expandable technologies in the coming months as well.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high-quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

IRVING, TX – January 20, 2023 – Astura Medical, a high-growth, innovative spine technology company, today has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its El Capitan X Expandable Anterior Lumbar Interbody System.

Constructed on the foundation of the success of the company’s integrated plate/spacer technologies and expandable interbody platforms, El Capitan X is a leap forward for what is now possible for anterior lumbar interbody fusion (ALIF) systems. The system provides a complete range of expandable anatomic spacers and fixation options with infinitely adjustable expansions in height and lordosis up to 30° for a unique, patient-specific solution.

El Capitan X’s intuitive design delivers a comprehensive range of infinitely adjustable construct options and expansive instrumentation that provide the versatility to address even the most complex anatomical challenges in a streamlined, efficient procedural sequence.

“The approval of El Capitan X represents a new benchmark for what’s possible in the anterior lumbar fusion marketplace,” said Thomas Purcell, Co-founder and Vice President. “By becoming the first and only system to combine integrated plate and spacer options, along with customizable expandable interbody capabilities, the system delivers on our goal of providing more intraoperative flexibility and versatility than any other ALIF system on the market. El Capitan X is redefining what it means to deliver a truly patient-specific solution.”

El Capitan X is Astura Medical’s 1st expandable technology platform with multiple fixation configurations to receive 510k approval. The company is scheduled to release El Capitan Oblique ALIF later this spring as well as introduce several new, expandable technologies in the coming months.

For more information, please visit El Capitan X or LinkedIn.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high-quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its El Capitan Oblique Anterior Lumbar Interbody Fusion (ALIF) System.

Built from the foundation of success with the company’s other integrated plate and spacer technologies currently addressing anterior cervical, lateral lumbar, and traditional anterior lumbar approaches, El Capitan Oblique was specifically designed to deliver the widest array of construct options with the most efficient and streamlined supporting instrumentation in the oblique anterior lumbar surgery marketplace today.

“With the rising demand for technology to provide anterior column reconstruction beyond traditional anterior and lateral lumbar approaches, we set out to provide a system that would establish a higher benchmark for intraoperative versatility, flexibility, and efficiency in oblique anterior lumbar surgery,” said Thomas Purcell, Co-founder and Vice President. “Thanks to the hard work and ingenuity of our engineering team and surgeon design partners, we were able to achieve our goal by delivering another best-in-class technology to our portfolio of solutions.”

In an effort to tailor to the specific needs of each patient, El Capitan Oblique is the first system to provide multiple, customizable plating and fixation options in oblique anterior lumbar procedures. The plating options from El Capitan Oblique allow for either a Zero-Profile, Half Plate, or Full Plate that can be implanted in combination with the interbody from either a left or right sided approach. By providing either Anchoring Nails or Screws, which can be delivered via multiple techniques including an All-in-One option, El Capitan Oblique can accommodate the wide variance of anatomical challenges presented in oblique anterior lumbar surgery.

El Capitan Oblique is the company’s fourth technology platform providing a combined interbody and fixation option to receive 510k approval. For more information on the El Capitan Oblique ALIF System, click here.

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

IRVING, TX – January 18, 2022

Astura Medical, a high-growth, innovative spine technology company, announced today the addition of Tom Frazer as Area Vice President of Sales, Midwest, and Brett Heim as Area Vice President of Sales, Northeast.

“We’re thrilled to welcome Tom and Brett to the Astura Medical Team,” said Steve Haayen, Vice President of Commercial Operations. “The wealth of expertise that both gentlemen bring across multiple facets of the spine marketplace, combined with their leadership skills will be valuable as we further scale our efforts of bringing best-in-class technology to an ever-growing group of surgeon and distributor partners.”

Tom Frazer brings over 22 years of spine sales and management experience to Astura Medical. Prior to joining Astura, he successfully put together dynamic and productive sales teams, ultimately resulting significant revenue growth during his tenure at organizations including Depuy, Medtronic, Stryker, and Globus.

Brett Heim has over 12 years of medical device sales and distribution experience highlighted by increasing roles of responsibility at organizations such as Medtronic and NuVasive, where he consistently achieved top honors by delivering high volume revenue growth and developing sales distribution
channels.

Later this year, Astura Medical will be launching several new technologies to its portfolio, including Sirion X Expandable LLIF, El Capitan X Expandable ALIF, El Capitan Oblique ALIF, and an extension of their Olympic Deformity System including Sublaminar Bands and Pedicle Subtraction Osteotomy (PSO) Instrumentation.

For more information, please visit us at www.asturamedical.com or LinkedIn.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

Media Contact:
Astura Medical
469.501.5530
info@asturamedical.com

Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Dolomite Stand-Alone Anterior Cervical Stabilization System.

Expanding on the rapid adoption and recent success of the company’s other integrated plate and spacer technologies for anterior lumbar and lateral lumbar procedures, Dolomite was designed to deliver the widest array of construct options with the most efficient and streamlined supporting instrumentation in the anterior cervical surgery marketplace today.

“Even in market segments that are well established and relatively commoditized, we are continuing to find ways to improve from other currently available technology,” said Joel Gambrell, Co-founder and CEO. “Dolomite is yet another example of our R&D Team, alongside our surgeon design partners, reestablishing the benchmark of what is considered to be the best-in-class solution for a specific procedure.”

Dolomite provides the choice of either HA PEEK or Acid-etched Titanium interbody spacers in an extensive range of heights, widths, and lordotic options. The system provides the intraoperative flexibility to select between either a zero-profile, half plate, or full plate that can be implanted in conjunction with the interbody. By providing either anchoring nails or screws, which can be delivered via multiple techniques including an “All-in-One” option, Dolomite provides a streamlined, repeatable set of solutions that can accommodate the varying anatomical challenges presented in anterior cervical surgery.

Dolomite is the company’s third technology platform providing a combined interbody and fixation option to receive 510k approval within the last 6 months.