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Captiva Spine Announces Alpha Launch of the TransFasten Posterior SI Fusion System

TransFasten™ Posterior SI  Fusion System 

Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to creating sincere and collaborative relationships to deliver smart, elegant, and intuitive spine fusion solutions. Today, Captiva Spine is announcing the alpha launch of the TransFasten Posterior SI Fusion System.  The TransFasten Posterior SI Fusion System was developed in conjunction with Robert Lins, M.D., Orthopedic Spine Surgeon at The Center for Bone & Joint Surgery of the Palm Beaches.

“My goal was to develop a safe and efficient posterior approach potentially reducing operative time, neurovascular complications, and achieving a quadracentric press fit that neither compresses nor expands the sacroiliac joint,” Dr. Lins explained.  “We are creating a fusion site similar to a mortise and tenon joint used in woodworking for thousands of years.” Dr. Lins continued to explain “TransFasten’s streamlined instrumentation and straightforward procedure provide for efficient joint preparation and precise press fit of a QuadraCentric Implant.”


To explain the QuadraCentric Joint Preparation simply…
A) Dock the QuadraCentric Drill Guide at the SI joint.
B) Ream the implant site.
C) Impact the QuadraCentric Implant and graft material.


“The launch of TransFasten (a posterior SI fusion system) is a key milestone in our drive to deliver clinical and economic value for patients, surgeons, and healthcare facilities,” said Dale Mitchell, President and Founder of Captiva Spine.

  • Posterior Approach – Potentially reduces operative time and Neurovascular complications.
  • Posterior Fusion Site Preparation – Allows for efficient preparation of the joint and press fit implant placement.
  • A form of “Mortise and Tenon” Stabilization of the SI Joint (a proven and established method of Architectural Stabilization) – The geometry of the TransFasten implant across the joint is designed to stabilize the motion segment without disrupting the anatomy and creating new pain generators.
  • Structural Allograft Implant – Custom allograft implant includes a large trans-joint graft window for accommodating a biologic fusion.

Training Opportunities Available. For more information, contact us at www.captivaspine.com/transfasten or call Captiva Spine direct at 561-277-9480.


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Captiva Spine Company Update

Captiva Spine Update: First TransFasten Cases; Hired VP Sales; Introducing HyperLOX

Captiva Spine Marks First Surgeries Using TransFasten™ Posterior SI Fusion System, Additions of VP of Sales & Business Development and HyperLOX™ Posterior Cervical System

Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine device solutions, announces the first surgeries using the company’s proprietary TransFasten™ Posterior SI Fusion System; the well-timed addition of Vice President of Sales and Business Development, Daniel Abromowitz; the addition of a new posterior cervical system – HyperLOX™.


Captiva Spine’s thoughtful solutions for the entire spinal column will be on display at the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting March 7-9, 2018 in New Orleans at booth 4213.


TransFasten Posterior Sacroiliac Joint Fusion System
TransFasten Posterior SI Fusion System

The first cases using the company’s proprietary TransFasten Posterior SI Fusion System were successfully completed across the USA starting in December 2017.  TransFasten’s use of a favorable posterior approach will potentially reduce operative time and neurovascular complications. With proprietary QuadraCentric joint preparation, TransFasten provides multiple implant contact points for biomechanical stability during fusion.  An initial TransFasten surgeon, Dr. Pedro Ramirez, M.D. of Central Florida Neurosurgery Institute, stated “the intuitive TransFasten instrumentation allows me to place the implant accurately, utilizing a safe posterior approach while obtaining a true biologic fusion of the sacroiliac joint.”  Over the past several years there has been a resurgence in the recognition of the SI Joint as a potential source of low back pain as treatment options for SI Joint dysfunction have advanced.  Captiva Spine is committed to launch devices that align clinical and economic outcomes on behalf of all key stakeholders.  TransFasten is on a track for completion of its alpha launch, and Captiva Spine will be training additional surgeons on this posterior SI approach nationwide as early as the end of March 2018.


Daniel Abromowitz VP Sales Business Development
Hired: VP Sales & Business Development, Daniel Abromowitz

In supporting Captiva Spine’s commitment towards continuous growth and business development, the addition of Daniel Abromowitz to Captiva Spine’s leadership team and business is significant. Dale Mitchell, Captiva Spine’s Founder and CEO, stated, “We have been looking forward to expanding our leadership team and increasing business presence throughout the USA.  Daniel is a welcome addition as a strategic business leader with a proven record of profitably building high-performing sales teams in the spinal device and healthcare marketplaces.”


HyperLOX Posterior Cervical Fusion System
Introducing: HyperLOX Posterior Cervical System

The commercial launch of the HyperLOX Posterior Cervical System provides Captiva Spine a comprehensive solution for posterior stabilization and fusion of the cervical and thoracic spine. HyperLOX can be constructed into a multitude of configurations based on individual patient anatomy.  Offering exceptional versatility and ease-of-use, HyperLOX features a wide range of hyper-angulating top loading polyaxial screws, hooks (straight, angled, and offset), offset connectors, multiple rod-to-rod connector configurations, cross connectors, and transitional rods.


Inquiries from tenured professionals looking to partner with a company to build a relationship for the long run are always welcome. Captiva Spine can be contacted direct by phone at 561-277-9480 or via their website www.captivaspine.com/contact-us.

Discover Strength Through Connections at www.captivaspine.com.

 

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. By valuing their relationships, above all else, 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: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

This Press Release can be found at PRWeb.com and is also featured on OrthoSpineNews.comORTHOWORLD, and Becker’s Spine.


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Barcode UDI compliance captiva spine

Upcoming Deadline for UDI (Unique Device Identification) Compliance

udi-unique-device-identifier

UDI Introduction

You may or may not be aware, as of September 24, 2016 the FDA is requiring a unique numeric or alphanumeric code (Unique Device Identification or UDI) on all labels and packaging for Captiva Spine’s implants. UDI applies to all U.S. industry implantable devices and we intend to make this transition as efficient as possible.

The goal is to establish a system to identify medical devices through their distribution and use, via the entire supply chain to point of use with patients.  We have been developing a process over the past few months to achieve this goal in an unobtrusive way to your work flow.

We will share this process with you over the upcoming months to help track these new identifier’s and allow for any questions you have of this new process. In the meantime, we wanted you to have a better understanding of UDI, so we have outlined information below to get the ball rolling.

Thank you for your continued support of Captiva Spine and we continue to be grateful for any opportunity to support your business.

  1. What is UDI?
  2. UDI General Rule
  3. Why are we doing it?
  4. Benefits of Unique Device Identification
  5. Conclusion

1. What is UDI?

A UDI is a unique numeric or alphanumeric code, which acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number.

  • Identifier/code on device label and packaging (and, in some cases, on the device itself) Two parts:
    • UDI = DI+PI * Device Identifier (DI) (static) – specific to a device version or model
  • Production Identifier(s) (PI) (dynamic) – one or more currently used control/production identifiers that is lot/batch number, serial number, manufacturing date, expiration date
  • If on the label – then needs to be part of the PI’s
  • Not requiring any changes to currently used PI’s

2. UDI General Rule

  • The label* of EVERY medical device (including all IVD’s) must have a UDI.
  • EVERY device package (contains a fixed quantity of a version or model) must have a UDI.
  • Any other approach is an exception to or alternative from these requirements.

3. Why are we doing it?

In keeping with the purpose and intent of the UDI rule, FDA reiterated that

“the goal is to establish a system for the adequate identification of medical devices through their distribution and use, via the entire supply chain to point of use with patients.”

FDA also stated that the direct mark requirement for implants in the proposed was not included in the final rule

“… because it was presumed that implants would be accompanied by their unique device identifier (UDI) label or package with UDI label up to the point of implantation.”

Healthcare providers have a lot to gain by jumping aboard the UDI train. By standardizing and cleansing source data, they can:

  • gain deeper insight into their spend,
  • prevent pricing and/or unit-of-measure errors,
  • level pricing across departments and facilities, and
  • aggregate spend throughout the supply chain.

4. Benefits of Unique Device Identification

When fully implemented, the UDI system may:

  • Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
  • Reduce medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
  • Enhance the FDA’s analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post-market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
  • Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
  • Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
  • Lead to the development of a medical device identification system that is recognized around the world.

5. Conclusion

UDI can fundamentally change and improve the way we all interact with medical devices. It can improve the way we order, purchase, securely distribute and safely and effectively use these devices. It will also inform cost and quality decisions.

But more importantly, it can vastly improve our understanding of devices, through a variety of focused and effective PMS activities, including longitudinal studies. This will allow for better understanding of the long-term safety and effectiveness of specific devices, their overall risk profile, and the use of devices in specific patient populations. And when problems do arise, we will be able to quickly identify and communicate with the affected patients in ways that simply don’t currently exist.

But all of this requires change. It requires device manufacturers to appropriately apply and use UDI on their device(s) and it requires everyone else involved in any aspect of device distribution and use, to adopt and implement systems to manage devices at their UDI level. And we believe that creative people will do all sorts of interesting and useful things based on a device’s UDI. But this will take significant time and resources to do.

However the end goal is well worth it. Just as we can’t even imagine a grocery store today without UPCs and scanners, we will have a hard time remembering the device world before UDI.
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If you have any specific questions about UDI, any of our products or just want to give us feedback, please contact customer service directly at 561-277-9480.

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* This is not original content. These are snippets of the guidelines that have been outlined by the FDA.