Author: SpineFrontier Admin

SpineFrontier, Inc's MISquito Percutaneous Pedicle Screw System in action.

SpineFrontier Enhances the MISquito Percutaneous Pedicle Screw System in Response to Growing Demand

SpineFrontier leverages Dr. Kingsley R. Chin’s extensive history of developing less invasive technologies since his invention of the MANTIS Percutaneous Screw System purchased by Stryker Corporation in 2005

SpineFrontier, Inc., the leader in Less Exposure Surgery (LES®) Technologies, announced today the next evolution in spinal fusion, the MISquito Percutaneous Pedicle Screw System (part of the PedFuse Pedicle Screw System platform). In contrast to the competition, SpineFrontier is focused on technique driven product solutions that provide maximum efficiency and enable outpatient, same-day surgery for patients. The MISquito’s advanced instrumentation and technique reduces exposure to fluoroscopy and eliminates the complexity of inserting of pedicle screws, pedicle rods, and locking caps in multilevel constructs.

Learn More About The Making of MISquito by Watching this Video:

Dr. Chin, orthopedic spine surgeon and CEO of SpineFrontier, says, “Almost every week I now use the MISquito for percutaneous lumbar fixation in an outpatient setting. The instrumentation makes it easy to perform fusions in a lateral position and for multilevel fusions from T2 to the sacrum with ease. I first started designing percutaneous pedicle screws in 2003 with the MANTIS and now 14 years later the MISquito is very advanced in its efficiency and simplicity. With the rise in number of fusions being performed, it is critical that we make these progressive leaps forward with our systems. We are now working on leveraging the design for scoliosis.”

The MISquito System continues to advance under the leadership and expertise of Dr. Chin, SpineFrontier’s rapidly expanding surgeon base, and their relationship with SpineFrontier’s accomplished Engineers and Designers who are trained to perform this surgery in the onsite cadaver lab. This extensive knowledge network ensures that no use scenario goes unexplored and ensures the instrumentation, in conjunction with the technique, overcome the limitations and intricacies of the competition.

Michael Emery, SpineFrontier Product Manager and Engineer of SpineFrontier’s Pedicle Screw platform “It’s exciting to continue to see the effective results of our Technique based Technologies through the relationship between our surgeons and engineers. The system boasts a first in-class implant engineered to accommodate a wide range of patient anatomy, bone density, and deformities. We accomplished this with our various screw offerings, built in reduction capability with superior tab strength, and progressive screw thread.”

SpineFrontier has enhanced the MISquito System to increase the ease and simplicity of putting in percutaneous screws and rods over multiple levels.

  • The flat blade dilator is designed to create a minimal incision size ideal for screw and rod insertion without excess tissue damage.
  • The locking screw inserter eliminates any toggle between the implant and instrument making it feel like one device. The locking mechanism ensures the screw is fully retained and does not unintentionally disassemble from the inserter.
  • A new implant configuration called REspond-XL that incorporates extended break off tabs with significant reduction threads for easy rod reduction
  • The threaded rod pusher allows for fully seating the pedicle rod into the saddle of the tulip
  • The new GEN II Rod Inserter was developed to ensure a rigid connection between instrument and implant to allow for rod and tulip manipulation in-situ during insertion. The mechanism allows for effortless insertion into the anatomy without the need for an additional incision.
  • The system also has a percutaneous compressor/distractor system that is less complex than competitor systems and fits into the technique flawlessly.

Indications:
The PedFuse Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis).

In addition, the PedFuse Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1).

About SpineFrontier Inc.
SpineFrontier Inc. is a growing medical technology company that designs, develops and markets both implants and instruments for spine surgery based on the Less Exposure Surgery (LES®) Philosophy. These technologies are designed to allow for outpatient surgery due to minimal disruption of normal tissues. SpineFrontier believes LESS is more: LESS time in treatment and recovery is more time in action for patients and surgeons. The LES Techniques drive the design process under the leadership and expertise of Dr. Chin, our surgeon experts, and engineering team that have access to our training lab and state of the art manufacturing facility to ensure that every use scenario is explored and design limitations are overcome. SpineFrontier is headquartered in Malden, MA. It was founded in 2006, and released its first products in 2008. SpineFrontier is a KICVentures portfolio company and the leader in LES technologies and instruments.

Contact
Phone: (978) 232-3990
Media: contact(at)spinefrontier(dot)com
Sales: sales(at)spinefrontier(dot)com
Engineering: MikeEmery(at)spinefrontier(dot)com

Arena-C HA Anterior Cervical Interbody is Making a Splash!

The amazing Arena-C HA technology

Due to surgeon demand, we are so excited to announce that the Arena-C HA anterior cervical interbody is now available in both 12 x 15 and 11 x 17 footprints. Check out the details of this amazing HA technology below.

SpineFrontier Arena-C HA Anterior Cervical Interbody is Making a Splash!

SpineFrontier Arena-C HA Anterior Cervical Interbody is Making a Splash!
SpineFrontier: From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws

From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws

Kingsley R. Chin, MD1, 2

Fabio J.R. Pencle, MB BS1

André V. Coombs, MB BS3

Mohamed Elsharkawy, MD3

Corrine F. Packer, MB BS3

Elijah A. Hothem, MD3

Jason A. Seale, MB BS1

  1. Less Exposure Surgery Specialists Institute (LESS Institute).
  2. Florida Atlantic University (FAU) & Florida International University (FIU)
  3. Less Exposure Surgery (LES) Society.
Conflicts of interest and sources of funding: We did not seek or receive any funding from the National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute (HHMI), or others for this work. KRC is a shareholder in and receives other benefits from SpineFrontier Inc., none of the other authors (FJRP, AVC, ME, CFP, EAH or JAS) have any potential conflicts of interest to declare for this work.

Abstract

Introduction

Modern advances in spine surgery including less invasive procedures have propelled the design of instruments and implants to achieve greater posterior spinal fixation, with decreased tissue destruction and higher safety margins.  Static and dynamic biomechanical studies have validated the superior pullout strength of cortical screws versus the traditional pedicle screws and might represent an opportunity to perform safe lumbar fusions in ambulatory surgery centers (ASC).  The authors aim to compare the outcomes of midline cortical pedicle screw surgical technique for posterior lumbar fixation in the ASC compared to traditional pedicle screws in a hospital.

Method

The medical records of 60 patients with prospectively collected data were reviewed. Two matched cohort groups consisting of 30 patients each, midline cortical pedicle screws performed in ASC patients (Group 1) was compared to traditional pedicle screws performed in Hospital patients (Group 2). Outcomes were measured using Visual Analog Scale (VAS) scores, Oswestry Disability Index (ODI) scores, estimated blood loss (EBL) and Radiologic fusion rate.

Results

33 males and 27 females, age range (28-75), average 58±3 years. Average BMI was 29±1.15 kg/m2. Significant improvement noted in VAS back pain scores in Group 1 from 7.8±0.5 to 2.5±0.7, p=0.001. Comparing VAS back pain scores and ODI scores, significant improvement demonstrated between group 1 and 2, p=0.004 and p=0.027 respectively. Mean EBL in group 1 was significantly less, p=0.025 than group 2. Intergroup fusion rate at two year was similar, p=0.855.

Conclusions

We successfully transitioned our lumbar fusions from hospitals to ambulatory surgery centers using a midline cortical pedicle screw technique. Although traditional pedicle screw placement was effective and may be viable in an ambulatory surgery center we see more advantages to use midline cortical screws over traditional pedicle screws.

SpineFrontier: From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws
SpineFrontier: From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws
SpineFrontier: From Hospital to Ambulatory Surgery Center: Midline Cortical Pedicle Screws Vs. Traditional Pedicle Screws

Texas Back Institute Embraces Sterilized Single Use Instruments

I was excited to read about the use of sterilized single-use spine surgery instruments at the Texas Back Institute. SpineFrontier is also developing sterilized single-use spine surgery instruments to be manufactured here in the U.S. We are looking for partner surgical centers (ASC) and hospitals to help us demonstrate the clinical and economic benefits of this new technology.

Dr. Guyer, the orthopedic surgeon (and past president of the North American Spine Society –NASS), together with orthopedic surgeon Dr. Zigler (a past president of the American Spinal Injury Association –ASIA) performed the minimally invasive lumbar fusion using Safe Orthopaedics’ single-use instruments. In Safe Orthopaedics’ press release, Dr. Guyer reported that the product was easy to use and generated substantial time savings.

In the same press release, Dr. Zigler commented on the easy training and time savings for surgeons: “For mini-invasive screw implantation the system is as user-friendly as any of the standard systems we use. The learning curve is minimal limited to 1or 2 cases for most if not all surgeons.”

By providing instrument kits and implants in packaging that’s already sterilized and easier to use, SpineFrontier wants to help customers improve patient care and significantly reduce healthcare cost. We believe sterilized, single-use instruments like Peel Pack will decrease infection rates and operational costs, eliminate the need for in-house sterilization and reduce the cost through bulk-purchasing. They will also help surgery centers reduce storage space for bulky kits and create an easy-to-manage inventory. Pre-sterilized surgical kits have the potential to deliver cost and time savings to surgeons in OR’s across the nation.