Device Spotlight

Behind the Scenes of a Huge SpineFrontier Team Milestone with SacroFuse

Behind the Scenes of a SpineFrontier Team Milestone with SacroFuse

This is one for the books! On April 26 we completed our first SacroFuse procedure during a very successful posterior sacroiliac joint surgery. Sending a huge thanks to the SpineFrontier and LESS Institute teams – both in the OR and at home – for making such a remarkable milestone possible.

Case photos from the surgery:

Behind the Scenes of a Huge SpineFrontier Team Milestone with SacroFuse
Behind the Scenes of a Huge SpineFrontier Team Milestone with SacroFuse

SacroFuse is a Less Exposure Surgery procedure that helps eliminate pain caused by sacroiliac joint disruptions and degenerative sacroiliitis. By reducing the irregular movement of the joint and stabilizing it, this technology can dramatically improve a patient’s quality of life.

Behind the Scenes of a Huge SpineFrontier Team Milestone with SacroFuse

Head to SpineFrontier’s website for detailed information on our innovative products and medical milestones. For training labs on Less Exposure Surgery technology and techniques, visit the LES Society and email contact@lessociety.org to be added to the mailing list for upcoming events.

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

SpineFrontier S-LIFT Lateral Interbody

Product Spotlight: S-LIFT Lateral Interbody

S-LIFT (Sagittal Lumbar Interbody Fusion Technology)

S-LIFT has a design that allows for a lateral approach to the anatomy, which enables a smaller incision size but also maintain a large footprint to provide stability within the patient.

“…the unique split rib design increases rigidity and robustness of the cage while also allowing for more graft to fill the interbody space during post-packing. This innovative feature creates opportunity for a fusion mass to form throughout the cage…”

Learn more about S-LIFT here.

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 and AxioMed recapturing the promise of total disc replacement

Recapturing the Promise of Total Disc Replacement

The story of the AxioMed Freedom® Disc is the story about a next-generation technology that has been developed for over a decade with the enormous hope of providing a solution for back pain. But as AxioMed developed and perfected its disc, the events of the total disc replacement (TDR) world swirled around it. Nothing can be understood apart from its context and that’s why AxioMed’s story is inevitably bound up in the story of the spine industry more broadly.

AxioMed believes its Freedom Disc’s design is a resoundingly solid answer to the questions patients and doctors have about total disc replacement in general. But how did those questions come to be such disquieting figures on the landscape of the spine industry? What happened to the promise of total disc replacement nearly a decade ago? Why did the excitement and intensity surrounding the idea that doctors, researchers and engineers could actually do something new and better in spine treatment dissolve?  To understand why AxioMed believes its disc is about to change the landscape of TDR, it’s important to first understand the context into which it bursts onto the scene.

In 2004, the DuPuy Charite™ Disc was led forth on the medical device market with high expectations as the first total disc replacement to be approved in the U.S. Many believed this would be the ultimate solution for degenerative disc disease (DDD) which is one of the most common causes of back pain –an ailment that plagues over 100 million adults in the U.S.[1]

The standard treatment for DDD was much the same in 2004 as it is today: spinal fusion.  Spinal fusion attempts to lessen the pain of a degenerated disc by fixating two or more vertebrae together to keep them from moving.  Unfortunately, the immobility achieved by fusion eliminates the natural motion with which the spine is intended to function. Fusion can also place extra stress on the surrounding vertebrae, hastening spinal degeneration in those segments as well.[2]

“The ability to replace discs could open up a new era in back treatment.”

As one might imagine, the promise of a total disc replacement that would treat DDD and also allow the spine to keep its movement was wildly attractive in 2004. The DuPuy marketing machine took advantage of their position as the first FDA-cleared total disc replacement technology in the U.S., and ramped up a considerable marketing effort that gained significant media coverage. [3] One writer in the Wall Street Journal predicted, “The ability to replace discs could open up a new era in back treatment,” but also ominously noted that the Charite’s implant’s long-term durability remained to be proven.[4]

After two years, the Charite Disc had failed rather spectacularly across national headlines. Lawsuits piled up and the tides turned against the Charite.  Dr. McAfee wrote about the theoretical disadvantages of the Charite: “Since artificial hips and knees were introduced in the 1960s, doctors have explored the idea of prosthetic replacements for damaged or degenerated intervertebral discs. The disc is a very complicated joint, so the engineering challenge to partially or fully replace a disc is considerable. Also, because disc injury is a common cause of back pain in younger adults (age 30 to 50), an artificial disc needs to be designed to last for decades.”[5]

New total disc replacements with different designs received FDA approval and entered the arena. But the excitement about TDR’s had wavered –not just because of Charite device failures, but also because it was difficult for doctors and patients to obtain insurance reimbursement for a TDR procedure.

Kari Zimmers, Sr. VP of Research and Development of AxioMed says, “One part of the story of total disc replacement is that no one queued up reimbursement as the first disc, Charite, was being approved for the U.S. market. This heavily impacted sales for Charite and the discs to follow.”

The small army of doctors excited to learn the newest and greatest total disc replacement treatment backed off until they could see long-term evidence of total disc replacement’s legitimacy and better insurance reimbursement. The bubble of total disc replacement was popped, leaving in its place a lingering attitude of skepticism that would become one of TDR’s greatest future opponents.

It’s been over ten years since Charite and other total disc replacements came out, and TDR treatments are starting to show long-term clinical results. From these studies, a few things about total disc replacement have become clear. Several clinical studies for cervical TDR’s have shown positive results. They indicate that TDR’s are at least as effective as fusion, and on certain points, statistically superior to fusion.[6]

Studies are showing that in the long run disc replacement is less expensive than fusion –an important point for those hoping that TDR’s can gain better reimbursement. A study in the June issue of Journal of Neurosurgery: Spine calculated the cost per quality-adjusted life year (the estimated cost of money associated with a medical intervention) for cervical disc replacement was $3,042, versus $8,760 for anterior cervical discectomy and fusion (ACDF)[7].  Another study in the peer-reviewed JAMA Surgery, showed that a two-level Mobi-C® Cervical Disc procedure was more cost-effective than performing a two-level ACDF.[8] Industry insiders are hopeful these results will underscore the value of TDR’s.

Lamenting the lingering skepticism about TDR’s in the face of sound clinical proof, Neel Anand, MD, Clinical Professor of Surgery and Director of Spine Trauma at Cedars-Sinai Spine Center in Los Angeles tells Becker’s Spine Review, “There has not been a single product in the history of orthopedics that has been studied as much as disc replacement or has more scientific data, cost analysis, radiographic outcomes and is still questioned by some in healthcare.“[9]

Although the long-term studies about total disc replacement are encouraging, existing designs have not yet been perfected. One of the major reasons total disc replacement suffered a setback is because early discs were designed as ball and socket joints, similar to the devices used for hip and knee replacements. These designs didn’t provide the right amount of motion and flexibility because the human disc is not a ball and socket joint, but is compressible and made of over 75% water.

This is where the strength of AxioMed’s disc design shines. The AxioMed Freedom Disc is a single-piece technology made of proprietary polymer that is permanently bonded between two titanium plates.  The polymer has viscoelastic qualities, meaning that it possesses the flexibility and stiffness similar to a normal human disc. AxioMed has an exclusive license on the polymer.  The Freedom Disc has been shown to respond to loading the way a human spine does and tests show it can stand the wear of decades of use.[10] Ultimately, the disc restores the stability, cushioning and three dimensional movement of a healthy, human disc.

For Kingsley R. Chin, the CEO of KICVentures and AxioMed, and a practicing orthopedic spine surgeon the history of AxioMed is an important link. KICVentures acquired AxioMed in 2014. The AxioMed Corporation was started in 2001 by a number of key surgeons, thinkers and engineers who used to work with Art Steffee on the AcroFlex Disc.  Art Steffee was one of the most prominent spine surgeons, entrepreneurs and innovators in the ‘80’s and ‘90’s.[11] AxioMed was a continuation of his work on TDR’s with the intent of solving the problems posed by the AcroFlex disc.

“The Acroflex Disc was one of the first viscoelastic discs, and that’s a true disc replacement,” says Dr. Chin. “If you look at the disc replacements on the market today, these are not real disc replacements. These are really multi-piece devices that move. They are ball and socket joints. The normal human disc is not a joint –it doesn’t move around –rather it acts as a shock absorber, compressing in multiple planes. The AxioMed technology that was developed since 2001 is now a true disc replacement, and it’s exciting to have a technology like this in spine.  In orthopedics we have knee, hip and shoulder replacements, and these are real joints and those technologies change lives and improve the quality of life. In spine, we did not have that before the AxioMed Freedom Disc. We had technologies that fuse the spine –screws and rods and bone graft that limit motion. Now with the AxioMed viscoelastic disc, we have a true opportunity to replace someone’s diseased disc and preserve motion. No more fusion and no excessive motion from ball and socket joints that may over time loosen or shed debris and create all kinds of problems.”

“It’s very important to us that this technology works to the highest standard,” says Dr. Chin.

Over the past 14 years, over $80 million has been spent by AxioMed to develop the Freedom Disc technology. Much of that money went toward making sure that the materials and amount of shock absorption were right and that the material was biocompatible. “It’s very important to us that this technology works to the highest standard,” says Dr. Chin. “We’ve done testing on this disc to show that if it is in the body for decades, it still functions as if you just put it in.”[12]

European studies published in peer-reviewed medical journals about the AxioMed Disc are backing up the talk with clinical results. In the EU there have been no device failures noted in the clinical literature for either the Freedom Cervical or Lumbar Discs at the time of this publication. In an EU clinical study, after two years, half of the patients with a Freedom Lumbar Disc had less than 10% disability score and reported less than 1/10 on the pain scale. [13] The Freedom Lumbar Disc provides better pain relief than anterior lumbar interbody fusion (ALIF) according to an EU clinical study.[14]  The Freedom® Lumbar Disc also performed better than competitor TDRs and is the first device to restore a normal center of rotation to patients (an important factor in keeping the rest of a patient’s spine aligned after the device is implanted). [15] [16]Both the lumbar and cervical discs are CE-marked and the lumbar disc has been implanted in patients in Europe since 2005. Dr. Oliver Hausmann, a neurosurgeon based in Switzerland and one of the early adopters of the AxioMed disc, says that the technology has performed well for him. His patients have had no side effects due to the device itself, and he is very happy with the two year results of the disc.  Dr. Hausmann chose the Freedom Disc because he likes the concept of the disc’s viscoelastic nucleus, its range of movement, its easy handling and its mobility on axial compression. When comparing the Freedom Disc to other TDRs, Dr. Hausmann says, “The Axiomed [disc] has a better range of movement than the ball and socket [discs].”

AxioMed is currently finishing its IDE on the lumbar disc and hoping to submit a PMA to the FDA by the fall of 2016. Ultimately, they hope to see the Freedom Lumbar Disc on the U.S. market in 2017. The Freedom Cervical disc completed preliminary clinical trials in Europe. AxioMed is raising capital in the United States to bring the cervical disc to the United States and start the IDE by 2016.

Meanwhile, the market for total disc replacement is strong and growing stronger. In Europe, the spine surgery devices market size is predicted to reach 2.37 billion by 2020, as the popularity of non-fusion devices and minimally invasive techniques grow with Europe’s aging population.[17] The Asia-Pacific spinal implant market is expected to double through 2022, reaching nearly $7 billion.[18] Others predict that motion preservation treatment will become the fuel for the spine industry, with 23% growth over next 5 years, $1.8 billion and a 45% of market share is here in US.[19]

For any company in the spine industry, these numbers represent exciting potentials for business growth. But for the people behind AxioMed, these numbers also represent countless opportunities to lessen people’s pain and give them a newer, better solution than the one the spine industry has been stuck in for decades.

[10] Benzel EC, Lieberman IH, Ross ER, Linovitz RJ, Kuras J, Zimmers K.  Mechanical Characterization of a Viscoelastic Disc for Lumbar Total Disc Replacement.  Journal of Medical Devices 5 (1), 2011.
[12] Benzel EC, Lieberman IH, Ross ER, Linovitz RJ, Kuras J, Zimmers K.  Mechanical Characterization of a Viscoelastic Disc for Lumbar Total Disc Replacement.  Journal of Medical Devices 5 (1), 2011.
[13] Rischke B, Ross RS, Jollenbeck BA, Zimmers KB, Defibaugh ND.  Pre-Clinical and Clinical Experience with a Viscoelastic Total Disc Replacement.  SAS Journal 5 (4); pp. 97-107, 2011.
[14] Rischke B, Zimmers K, Smith E.  Viscoelastic Disc Arthroplasty Provides Superior Back and Leg Pain Relief in Patients with Lumbar Disc Degeneration Compared to Anterior Lumbar Interbody Fusion.  International Journal of Spine Surgery 9; July 2015.
[15] Rischke B, Kammermeier V, Runkel M, Zimmers K, Kuras J.  Clinical Outcomes for a Viscoelastic Total Disc Replacement Compared to Other Total Disc Replacements in the SWISSspine Registry.  Presented at the International Society for the Advancement of Spine Surgery (ISASS) Annual Meeting, Barcelona, Spain, March 2012.
[16] Newton Ede M, Ross ERS, Rischke B, Joellenbeck B, Hipp J, Zimmers K. An Association Between the Center of Rotation and Clinical Outcome in Patients Implanted with a Viscoelastic Total Disc Replacement.  Proceedings of the British Orthopaedic Association Congress, 2011.
[17] Ibid.
AxioMed to Bring its Cervical Viscoelastic TDR to US

AxioMed Plans to Bring Cervical Viscoelastic Total Disc Replacement to US

Plans underway to initiate the Cervical IDE for the Freedom Disc in the USA

There have been many surgeons lamenting the lack of innovation at national spine conferences. “We aim to change that perception starting with the CSRS meeting this year in San Diego,” says Dr. Kingsley R. Chin, Orthopaedic Spine Surgeon and CEO of KICVentures. Dr. Chin is a Henry Bohlman fellowship-trained spine surgeon who has the same strong interest in cervical spine surgery as his mentor, so it was no surprise when he convinced the KICVentures team to acquire AxioMed Corporation in November 2014.

Dr. Chin will be attending the Cervical Spine Research Society (CSRS) meeting in San Diego, Calif. on Friday, Dec. 4 and Saturday, Dec. 5 to meet with other surgeons who have shown an interest in bringing the AxioMed viscoelastic total disc replacement technology to the U.S. Market to initiate IDE trials in 2016.

AxioMed’s total disc replacement, the Freedom® Disc, is a single-piece technology made of proprietary polymer that is permanently bonded between two titanium discs. Its viscoelastic core simulates the stability and flexibility of a healthy human disc. The Freedom Disc has been implanted in over 800 patients globally and has performed well on the European market. Clinical results show that the AxioMed discs display superior strength, durability and enhanced range of motion when compared to that of a healthy, human disc.

“This technology is the next generation of total disc replacement and is designed to mimic the natural anatomy of a human disc.”

“This technology is the next generation of total disc replacements and is designed to mimic the natural anatomy of a human disc. Unlike current discs on the market that are miniaturized versions of a total knee replacement ball and socket joints, the AxioMed lumbar and cervical discs are compressible, single-piece devices with no moving parts. The proprietary viscoelastic material is the only proven material to perform as a disc replacement in the spine and KICVentures has the exclusive license in the spine for its lumbar and cervical discs and any other applications. We want to bring back the excitement and optimism for disc replacement that we experienced in 2004 with the introduction of the first FDA cleared lumbar disc replacement,” says Dr Chin.

Plans underway to initiate the AxioMed Cervical IDE for the Freedom Disc in the USA

The Freedom Disc has received global attention. Dr. Pflugmacher, Head of Spine Orthopedics, University Hospital of Bonn, Germany, calls the Freedom Disc the “best disc on the market.” The lumbar disc IDE trials are coming to an end in a few months and AxioMed plans to submit the PMA to the FDA in 2016 and hopes to release the lumbar disc in the USA in 2017. The disc is available outside the USA and is exclusively distributed by SpineFrontier.

About AxioMed

Founded in 2001, AxioMed began its journey of exhaustively proving the Freedom Disc through research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology. Visit AxioMed at axiomed.com.

About KICVentures

KICVentures manages several portfolio companies, investing in disruptive technology in the health-tech sector. KICVentures acquires, creates, and nurtures companies and their technologies to their fullest potential. Visit KICVentures at KICVentures.com.

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
Jamaica’s First A-CIFT™ SoloFuse-P™ Case LESS Institute Gives Back - SpineFrontier

The LESS Institute Gives Back: Jamaica’s First A-CIFT SoloFuse-P Case

On July 3, 2015, Dr. Kingsley R. Chin of the LESS Institute in Florida and Jamaican Neurosurgeon Dr. Franz Pencle performed a Less Exposure Surgery procedure on a middle age, male patient who suffered from severe myelopathy (spinal cord compression) due to a progressive degenerative disorder. The procedure took place at Cornwall Regional Hospital in Montego Bay, Jamaica. Before surgery, the patient was incapacitated. “He was basically quadriplegic,” Dr. Fabio Pencle, a LESS Institute Research Fellow who supported the case says. “On his strength test, he scored a 1/5 throughout all limbs –which means he could barely flicker his digits.” Dr. Fabio Pencle believes that the patient survived because of treatment. “Patients with similar symptoms demised because they didn’t receive timely treatment,” says Dr. Fabio Pencle.

Dr. Chin, Dr. Franz Pencle and Dr. Fabio Pencle donated their time for the case and SpineFrontier, Inc. donated the SoloFuse hardware. The Less Exposure Surgery (LES) procedure was performed through a midline cervical incision, dissection to expose the affected level and a discectomy using rongeurs and burr. A DBM packed A-CIFT SoloFuse was placed and fixed with screws. This was the first case of a standalone implant in Jamaica. It was also the first outpatient spine surgery done at Cornwall Hospital. The patient could sit upright twelve hours after surgery, and he tested 5/5 on a strength test in the upper limbs and 4/5 in the lower limbs –indicating that he had significant improvement in less than 24 hours.

About SpineFrontier’s A-CIFT™ SoloFuse-P™

The A-CIFT SoloFuse-P standalone Less Exposure Surgery system features a simple dual screw construct, a large graft window, large diameter screws, and slim, agile instrumentation. Its zero-profile and all PEEK-OPTIMA Natural design minimizes tissue disruption.

Introducing the SIJ-Fuse Screw: Making Treatment Better through LES Technology

Introducing the SIJ-Fuse Screw: Making Treatment Better through LES Technology

The SIJ-Fuse Screw is a fenestrated, hollow rod used to fuse the sacroiliac joint. Dr. Kingsley R. Chin and SpineFrontier’s Medical Advisory Board developed the concept for an improved sacroiliac joint (SIJ) fusion system to improve patient recovery time and outcomes.

In the past, SIJ fusion procedures required three fusion rods. But the SIJ-Fuse Screw’s innovative design only requires two rods. By offering more surface area per screw, the SIJ-Fuse provides the same strength of fixation as older systems, but with fewer rods – leading to fewer incisions.

The fenestrations, or holes in the rod enable surgeons to fill the implant with bone graft, increasing the likelihood of boney in-growth and fusion. This all leads to less surgical time, making SIJ-Fuse an emblematic Less Exposure Surgery Technology. It is with great pride that the SpineFrontier team introduces SIJ-Fuse to the world as they look forward to FDA approval later this year.

Dr. Mark W. McFarland Successfully Completes Surgery Using SpineFrontier's® Less Exposure Surgery A-CIFT™ SoloFuse-P™

Dr. Mark W. McFarland Successfully Completes Surgery Using SpineFrontier’s® Less Exposure Surgery A-CIFT™ SoloFuse-P™

Check out our latest press release about Dr. McFarland’s A-CIFT SoloFuse-P Case!

Newport News, VA

Orthopaedic & Spine Center announced today that Dr. Mark W. McFarland successfully implanted SpineFrontier’s A-CIFT™ SoloFuse-P™. The operation took place on Thursday, June 4, 2015 at Bon Secours Mary Immaculate Hospital in Newport News, VA. The procedure was an anterior cervical discectomy and fusion on a 57 year old, male patient.  The patient suffered from both neck pain and bilateral shoulder pain as a result of stenosis at the operative level C3-4. Prior to undergoing surgery, the patient failed conservative treatments including physical therapy and anti-inflammatories.

SpineFrontier’s A-CIFT SoloFuse-P is a Less Exposure Surgery (LES®) technology. LES technologies are designed with outpatient surgery in mind and strive for less disruption of the tissues. The A-CIFT SoloFuse-P standalone, intervertebral body fusion device is a Less Exposure Surgery System featuring a simple, dual screw construct, a large graft window, large diameter screws, and slim, agile instrumentation. Its zero-profile and all PEEK-OPTIMA Natural design minimize tissue disruption.

Dr. McFarland remarked on the advantages of SoloFuse-P’s design in the operation: “Today’s case demonstrates an extremely minimally invasive surgical technique to fuse the cervical spine.  The new SoloFuse standalone device eliminates the need for an overly aggressive surgical exposure or removal of previous spinal instrumentation. It serves to minimize our patients’ post-operative discomfort and speed their final recovery.”

SpineFrontier engineer Lucas Diehl explained how A-CIFT SoloFuse-P leverages the familiarity of existing techniques while providing an alternative to cumbersome plating for one-level procedures. “Its standalone design makes implantation easier. The technology was designed with surgeons in mind. It’s easy. It’s simple. It’s consistent,” said Lucas Diehl.

Dr. McFarland currently practices orthopaedic surgery at the Orthopaedic & Spine Center in Newport News, VA where he focuses primarily on the care and treatment of injuries and disorders of the spine. Dr. McFarland graduated from Oklahoma State University Medical School in 1999. He completed his residency in orthopaedic surgery at Ohio University and then went on to complete an Orthopaedic Spine Surgery Fellowship at the Florida Spine Institute in Clearwater, Florida. Dr. McFarland is a member of the American Academy of Orthopaedic Surgeons and the American College of Osteopathic Surgeons. Among other honors, he received the “Graduating Physician Academic Excellence Award.” His research includes studies on vertebral compression fracture outcomes.

Also check it out on PRWeb & Boston.Com.