Tag Archive for: Pedicle Screws

Captiva Spine Shares the Publication of a Prospective Randomized Comparative Clinical Study of Accuracy and Safety Data in line with the WatchTower Spine Navigation System

Study: 3D surgical navigation compared to navigation systems that utilize intra-operative CT scanners.

Jupiter, FL – April 2024 – Captiva Spine®, a medical technology organization connecting healthcare professionals, distribution specialists, and healthcare facilities with cutting-edge spinal care technology, shares a recently published study in the Journal of Neurosurgery: Spine (JNS), affirming the effectiveness of the WatchTower Spine Navigation System and its novel 2D registration of a pre-operative CT for real-time 3D surgical navigation compared to navigation systems that utilize intra-operative CT scanners.

Enhanced Precision, Safety, and ASC Economics

Real-time 3D surgical Navigation is emerging as the standard of care in spine surgery. It has been shown to minimize radiation exposure for surgeons and staff while enhancing the surgeon’s view of the anatomy.

To date, navigation systems have relied on intra-operative CT scanning or touch registration of a pre-op CT scan to facilitate 3D navigation.  These methods of importing medical imaging into the operating room: 1) Require open exposures, in the case of touch systems, that limit the value of the technology for percutaneous procedures. -or- 2) An intra-operative CT scanner is required, which, while preserving percutaneous procedure capabilities, is cumbersome for surgical workflow and expensive for acquisition.

The WatchTower Spine Navigation System streamlines the surgical workflow by registering a pre-operative CT scan into the operating room with 2D c-arm imaging, using a sophisticated algorithm to provide real-time 3D navigation during surgery. This allows the surgeon to percutaneously navigate instruments and implants with enhanced accuracy, reduce intra-operative radiation for the patient and staff, and do so with the equipment the facility already owns, a c-arm, eliminating the need to purchase an intra-operative CT scanner.

Accurate. Efficient. Reduced Radiation. Backed by Clinical Research.

The registration method and algorithm used in the WatchTower SNS system was the subject of a recent randomized study comparing it to an intra-operative CT scan-based system. A team led by Jau-Ching Wu MD, PhD, a Neurosurgeon at Taipei Veterans General Hospital and Assistant Professor at the National Yang-Ming University (et al.) has published a study in the Journal of Neurosurgery: Spine (JNS)1, “Comparison of intraoperative cone-beam CT versus preoperative fan-beam CT for navigated spine surgery: a prospective randomized study,” highlighting the clinical utility and benefits of the unique registration method compared to a commonly available intra-operative CT-based navigation platform. The study concludes that the preoperative CT-based spinal navigation system matches the accuracy and safety of the conventional CT-based intra-operative system. Additionally, it offers the advantages of a more rapid workflow and lower intra-operative radiation exposure.

Captiva Spine’s ASC-READY WatchTower Spine Navigation System will be featured at the ISASS (International Society for the Advancement of Spine Surgery) Annual Meeting held in Miami Beach, FL, April 27-28, 2024. 

The President of Captiva Spine, Dale Mitchell, reflected on the recent JNS article, “The clinical experience documented in the recent JNS study demonstrates that excellent outcomes are achieved with the WatchTower SNS platform.  This has profound market implications as it shows that 3D surgical navigation can be performed using pre-operative imaging without touch registration or the need for intra-operative CT scanning.” 

Mitchell continued, “Eliminating the need for intra-operative scanners or open registrations for the first time provides a cost-effective navigation platform for the ASC environment and community hospital a reality.  The WatchTower SNS underscores Captiva Spine’s commitment to providing clinical and economic solutions to the market.”

Get Enabling Technology in Your Facility

For those interested in seeing the ASC-READY WatchTower Spine Navigation System in action, along with our range of cervical, lumbar, and SI fusion solutions, Captiva Spine® invites you to visit our website at www.captivaspine.com/spine-navigation to schedule a demonstration. We welcome inquiries from healthcare providers, surgical facilities, and distribution professionals. To get in touch with us directly, please email our team at info@captivaspine.com

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About Captiva Spine, Inc. 

Captiva Spine, founded in 2007, is a privately held medical device company that brings healthcare providers, distribution professionals, and surgical facilities together with innovative spinal care solutions. With a focus on quality, Captiva Spine strives to create reliable systems that provide clinical and economical solutions to the spine market.

Captiva Spine – Navigating Today.

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This Press Release is also featured on PrWeb.com

  1. Published online November 24, 2023; DOI: https://doi.org/10.3171/2023.9.SPINE23422
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Captiva Spine WatchTower Spine Navigation First Case in US using enabling technology

Captiva Spine Announces Completion of First U.S. Cases with the New WatchTower Spine Navigation System, “A game-changer for facilities doing spine surgery.”

Captiva Spine WatchTower Spine Navigation First Case in US using enabling technology

WatchTower™ Spine Navigation and Robotics: Sophisticated 2D Registration Algorithm Eliminates the Need for Intraoperative 3D Imaging

Captiva Spine, a spinal technology organization dedicated to providing clinical and economical solutions in spine care, announced the completion of the first U.S. cases series using their new state-of-the-art WatchTower Spine Navigation System. The surgeries were performed by Dr. Hunaldo Villalobos of the Central Florida Neurosurgery Institute at facilities in the Orlando, FL, area.

The WatchTower Spine Navigation and Robotics Systems streamline the surgical workflow by merging a pre-operative CT scan with 2D imaging using a sophisticated algorithm to provide real-time 3D images of the patient’s spine during surgery. This allows the surgeon to navigate the spine with enhanced accuracy and precision, intended to improve patient outcomes and reduce the risk of complications. Additionally, the system eliminates the need for intraoperative 3D imaging for registration, minimizing operative time and radiation exposure for patients and staff and enhancing the safety and efficiency of spine surgeries.

“A fast, accurate, and inexpensive system makes navigation equipment installation at an ambulatory surgery center (ASC) feasible.”

“Captiva Spine’s WatchTower will be a game-changer for facilities doing spine surgery.” Said Dr. Hundaldo Villalobos.  “The system’s ability to register without relying on intraoperative CT scans or surface mapping through an open exposure makes it highly efficient and able to transform procedural workflow.” Dr. Villalobos further mentioned, “Speed of workflow was very impressive, including a decrease of set up time and implementation for the entire staff. Having a fast, accurate, and inexpensive system makes navigation equipment installation at an ambulatory surgery center (ASC) feasible.”

Dale Mitchell, President of Captiva Spine, expressed excitement over the first US cases with the WatchTower Spine Navigation System, stating, “We are thrilled to see our technology making a real impact in the operating room. Our team has worked tirelessly to bring this system to market and ensure its sophisticated technology is still practical and easy to use.  This milestone reinforces our vision of providing clinical and economical solutions to the market.”

Get Enabling Technology in Your Facility

WatchTower Spine Navigation System US placements will be available by the end of 2Q23. For more information about the Captiva Spine WatchTower Spine Navigation and Robotics System and our other spinal fusion solutions, please visit www.captivaspine.com/spine-navigation

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To take advantage of Captiva Spine’s innovative technologies and incorporate them into your healthcare offerings, please don’t hesitate to contact us. We welcome inquiries from healthcare providers, surgical facilities, and distribution professionals. To get in touch with us directly, please email our team at info@captivaspine.com

See More Details

About Captiva Spine, Inc. 

Captiva Spine, founded in 2007, is a privately held medical device company that brings healthcare providers, distribution professionals, and surgical facilities together with innovative spinal care solutions. With a focus on quality, Captiva Spine strives to create reliable systems that provide clinical and economical solutions to the spine market.

Captiva Spine – Navigating Today.

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Daniel McPhillips
Director of Enabling Technologies & Market Development
561-277-9480 ext. 706

This Press Release is also featured on: PrWeb.com, OrthoSpineNews.com, Orthoworld.com, Spine-Market.com, SPINEMarketGroup           

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real-time 3D spine navigation and robotics

Captiva Spine Expands Management Team to Support Roll-out of the New WatchTower™ Spine Navigation and Robotics System

watchtower spine navigation and robotics for MIS spine surgery

WatchTower™ Spine Navigation and Robotics: Expanding Management Team

Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant, and intuitive spinal fusion solutions. Today Captiva Spine announced the expansion of its management team to accelerate the roll-out of its WatchTower Spine Navigation and Robotic System. Daniel McPhillips has joined Captiva Spine as the Director of Enabling Technologies and Market Development. “Dan will be a great asset to the roll-out of the WatchTower Spine Navigation and Robotics System,” said Dale Mitchell, President of Captiva Spine. “Dan has been at the forefront of numerous technological inflection points in the spine market going back to the first MIS pedicle screw systems and cage IDE/PMAs. His most recent experience focused on innovations in percutaneous interbody fusion.”

The WatchTower Spine Navigation System promises to provide surgeons with a next-generation navigation and robotics system for the Ambulatory Surgery Center (ASC) and specialty hospital. WatchTower Spine Navigation eliminates the need for inter-operative CT imagery. This offers exceptional procedural efficiency, radiation safety, and a cost-effective navigation solution for these new service sites. The spine navigation system has received 510(k) clearance from the FDA (U.S. Food and Drug Administration) and is available for commercial use.

The WatchTower Spine Navigation and Robotics System eliminates the need for intraoperative CT imagery. This offers exceptional procedural efficiency, radiation safety, and cost-effective navigation…

“Spinal fusion procedures have become less invasive and post-operative significantly more effective, making same-day lumbar fusion surgery a reality,” said Dan McPhillips. “This, along with the recent changes in the CMS in-patient-only list, makes ASC MIS spinal fusion a real opportunity for surgeons and patients. I am excited to join Captiva because the WatchTower Spine Navigation and Robotics System offer advanced spine navigation capabilities yet are economically practical for the ASC setting.”

Vertical Integration at Captiva Spine

“At Captiva Spine, we always strive to provide smart, elegant, and intuitive spinal solutions, but more than that, we are working to provide a solid vertically integrated procedural platform,” said Dale Mitchell. The WatchTower System is a synergistic addition to support our newest generation TowerLOX-EXT MIS Extended Tab Pedicle Screw System and TransFasten Posterior SI Joint Fusion System.”

TowerLOX-EXT is the next-generation extended tab MIS screw system from Captiva Spine. It affords the surgeon the state-of-the-art MIS extended tab design they expect with significantly more reduction and spinal re-alignment utility than other systems on the market. 

The TransFasten Posterior SI Fusion System is a unique approach to posterior MIS sacroiliac joint fusions, offering increased efficiency while reducing the invasiveness of traditional sacroiliac joint fusions. The system’s patented carpentry has been developed to ensure ease of use, immediate stabilization of the motion segment, and an optimal environment for fusion. Experience the benefits of TransFasten for yourself and discover how our innovative system may help achieve the results patients are looking for.

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To take advantage of Captiva Spine’s innovative technologies and incorporate them into your healthcare offerings, please don’t hesitate to reach out to us. We welcome inquiries from healthcare providers, surgical facilities, and distribution professionals. To get in touch with us directly, please email our team at info@captivaspine.com

See More Details

About Captiva Spine, Inc. 

Captiva Spine, founded in 2007, is a privately owned medical device company that brings healthcare providers, distribution professionals, and surgical facilities together with innovative spinal care solutions. With a focus on quality, Captiva Spine strives to build and maintain sincere, honest, and collaborative relationships to earn mutual trust and openness. By doing so, we aim to become the preferred provider of smart, elegant, and intuitive spine care solutions.
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Daniel McPhillips
Director of Enabling Technologies & Market Development
561-277-9480 ext. 706

This Press Release is also featured on: PrWeb.com, SpineMarketGroup, Spine-Market.com,  OrthoSpineNews, Becker’s Spine Review,                     

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real-time 3D spine navigation and robotics

Captiva Spine announces an exclusive strategic partnership with REMEX Medical for Spine Navigation and Robotics, adding to their expanding product portfolio

Spine Navigation and Robotics: Exclusive Strategic Partnership 

Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant, and intuitive spinal fusion solutions. They announced today its long-term exclusive strategic partnership with REMEX Medical, a developer of advanced navigation and robotics technologies located in Taichung, Taiwan; for real-time 3D spine navigation with future developments in practical robotic solutions.

Captiva Spine looks forward to serving the substantial demand and need for both navigation and surgical robots for spinal applications. For underserved hospitals and Ambulatory Surgery Centers (ASCs) throughout the U.S., this technology will serve as a platform to expand the company’s products and services with enhanced enabling technology to support MIS technology.  Specifically, Captiva Spine will be starting with their CapLOX Pedicle Screws, TowerLOX-EXT MIS Extended Tab Pedicle Screws, and TransFasten Posterior SI joint fusion system.

Future Developments in Spine Navigation and Robotics

Nelson Lin, CEO of REMEX Medical, said, “we are very pleased to enter the US marketplace with our new strategic partner, Captiva Spine. We share an enthusiasm and commitment to providing ongoing advancements for the betterment of spine care. REMEX has been researching and developing this platform for eight years with proven clinical performance.”

The navigation system has 510(k) clearance from the FDA ( U.S. Food and Drug Administration) and is available for commercial use. The navigation unit is a small on-site unit for more facilities looking to take advantage of the benefits of readily available, easy-to-use spine navigation. This model offers physicians, orthopedics, and neurosurgeons easy-to-use, cutting-edge technology to pre-plan and visualize their surgical approach. This platform utilizes preoperative CT scans and rapid intraoperative registration for accurate real-time 3D navigation with limited radiation exposure to staff and patients.

Cost-Effective, Real-Time 3D Navigation and Robotics that’s user-friendly

The spine navigation platform will be demonstrated at Captiva Spine’s booth (#3731) at the 2022 North American Spine Society (NASS) Annual Meeting, in Chicago, IL, October 12-14.

“This platform for spine navigation helps fulfill our commitment to being a clinical and economical solution with advanced enabling technology for spine care,” said Dale Mitchell, President of Captiva Spine. “We plan to have a technically advanced navigation platform to improve spine procedural efficiency and be economically feasible for the growing number of ASCs and specialty hospitals throughout the United States,” Mitchell continued.

Improving and Expanding the Spine Navigation Platform

Spine Navigation allows surgeons to oversee the precise placement of MIS pedicle screws while situated directly at the operation site, guided by navigation technology. “Our goal is to provide a technology for reproducibility of screw accuracy and placement with higher confidence and safety in difficult areas is also a goal in mind, as well as improving screw insertion times, especially in cases of difficult anatomy,” said Mitchell.

Captiva Spine is planning to expand the system’s capabilities to include robotics. Both platforms are intended to improve the reproducibility and accuracy of applicable procedures to meet the growing demand for enabling solutions worldwide.

Inquiries from physicians and industry professionals looking to incorporate intelligent and innovative technologies into their offerings are always welcome. Captiva Spine can be contacted directly by phone at 561-277-9480. 

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About Captiva Spine, Inc. 

Captiva Spine is a privately owned medical device organization founded in 2007.  Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities.  In providing patients with progressive spinal care and an obsessive focus on quality, they strive to create and maintain sincere, honest, collaborative relationships. Valuing their relationships fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high-quality, smart, elegant, and intuitive patient solutions. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically. While never losing sight of what they refer to as the Human Factor, they find joy in their daily lives and serve the needs of their customers with sincere, professional enthusiasm.

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