Cases

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.

100th Less Exposure Surgery Procedure Completed by Industry Leading Surgeon Dr. Jeffrey Carlson

100th Less Exposure Surgery Procedure Completed by Industry Leading Surgeon Dr. Jeffrey Carlson

Newport News, Virginia –Tuesday, June 30, 2015

Orthopaedic & Spine Center announced today that Dr. Jeffrey R. Carlson finished his 100th case using SpineFrontier’s® PedFuse® REmind® Screws. The operation took place on Tues., June 30, 2015, at Bon Secours Mary Immaculate Hospital in Newport News, VA. The procedure was an L5-S1 posterior lumbar interbody fusion on a 69 year old, male patient. Prior to undergoing surgery, the patient suffered constant pain and failed conservative treatments including chiropractic treatments and steroid injections.

Dr. Carlson’s milestone case represents a significant achievement in the innovative, Less Exposure Surgery (LES®) midline approach. Implanting PedFuse REmind screws via the LES midline approach minimizes tissue disruption and results in smaller incisions. It may also reduce blood loss, and surgery time while potentially speeding up the patient’s recovery.

Less Exposure Surgery (LES) is based on a new philosophy of doing surgery. LES is less invasive than MIS. LES incisions are small incisions through which the surgeon only exposes what needs to be treated for maximum effectiveness. By developing innovative technologies and techniques tailored for pinpointing the problem and fixing it without collateral damage, LES minimizes normal tissue disruption without relying on excessive radiation.

Dr. Carlson remarked on the LES technique, “Advancements in spine surgical techniques are now allowing patients to have outpatient lumbar fusions. SpineFrontier continues to lead in techniques that decrease the pain of surgery and provide the same outcomes as standard procedures. Less pain, less blood loss, and quicker recoveries are the driving force behind these new techniques.”

Susan Finkel, a patient of Dr. Carlson’s who underwent an outpatient Less Exposure Surgery midline procedure, emphasized the ease of her recovery. “Having this done was one of the best decisions that I have ever made and being able to go home within a few hours of surgery and being able to return to work so quickly made this the easiest surgery I’ve ever had.”

Dr. Carlson is a board-certified orthopedic surgeon, focused on treating spine disorders. He received his M.D. from George Washington University in 1993 and completed his residency in orthopaedics at the Harvard Medical School Hospitals (Massachusetts General Hospital and Brigham and Women’s Hospital). He also completed an Orthopedic Trauma Surgery Fellowship and a Spine Surgery Fellowship. Dr. Carlson is a managing partner of the Orthopaedic and Spine Center in Newport News, VA and served as Chief of Surgery at Bon Secours Mary Immaculate Hospital.

Dr. Carlson is a long-time supporter of the Arthritis Foundation. As an expert in his field, he has published and lectured extensively on the subject of orthopedics and has appeared on television several times. In 2008, Dr. Carlson was one of the first surgeons in his area to perform a cervical disc replacement.

About the PedFuse REmind Midline Screw Family

SpineFrontier designed the PedFuse REmind Midline Screw Family under the unifying umbrella of LES midline tissue-preserving surgery. The PedFuse Pedicle Screws use CortiCan™ thread technology, which means the wider space between threads at the tip of the screw bonds it to the less dense, cancellous bone interior and threads grow closer together at the proximal head of the screw to grip the harder, cortical shell on the surface of the bone.

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. SpineFrontier is headquartered in Beverly, 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.

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.

LESS Talk, More Doing: Changing Lives in Jamaica, SpineFrontier Less Exposure Surgery story

LESS Talk, More Doing: Changing Lives in Jamaica

On a late Saturday night in May, an unlikely group of people’s paths crossed in a small operating room in the University Hospital of the West Indies. It was hot, and beads of sweat formed on the doctors’ foreheads above their surgical masks. Outside the O.R., the windows in the hallways were open to catch the breeze that filtered through the open slats. The hallway was quiet, filled only with an empty gurney with a canvas stretcher and wood handles. A clock on the wall covered in a metal casing methodically tracked the passing moments.

Inside the O.R., Dr. Kingsley R. Chin, an orthopaedic surgeon and founder of Less Exposure Surgery Specialists (LESS) Institute in Florida, and Dr. Carl A. Bruce, a consultant neurosurgeon at the University of the West Indies at Mona Jamaica, operated on a fifteen year old young woman. Around them stood Kevin Chappuis, a medical technology engineer from SpineFrontier, Inc, Harisha Buggam, a medical device distributor in the West Indies, and the University’s Chief of Anesthesiology, Dr. Harding. The operation, a high level, scoliosis case, required that surgeons correct a deformity in the patient’s spine.

Shinel Binns, the patient lying on the operating table, was fit and healthy -a normal young woman in every way, except for the severe curve in her spine. Standing up, Shinel’s legs were perpendicular to the ground, but at her waist, her torso and head angled sharply to the left, as if she had to fight gravity from pulling her left shoulder and head to the ground. A lifetime of trying to hold her head and torso upright to counterbalance her lumbar spine’s deformity had begun to create a curve in her thoracic spine.

Shinel lived in Saint Elizabeth Parish –a two hour journey from the hospital she was now being treated at in Kingston, Jamaica. She and her family had waited a long time for this moment. She would never have been able to afford an operation, but the donated time from the doctors, and over $500,000 in donated technology and personnel from SpineFrontier, as well as her community’s donation of $5,000, was making her operation possible.

Dr. Kingsley R. Chin had flown in earlier that day from the United States. Born and raised in Jamaica, he often returned to perform surgeries for people in need. As a pioneer in the Less Exposure Surgery (LES®) approach, Chin has devoted his life to refining and training others in a revolutionary approach to back surgery. The LES Philosophy of surgery pinpoints the problem, fixes it without collateral damage to surrounding tissues, and lets patients go home the same day.

A patient examination and X-Rays had confirmed to the doctors that Shinel’s original spinal deformity was in the lumbar spine. Because the thoracic curve was compensatory to keep her upright, Dr. Chin and Dr. Bruce operated on the most pronounced section of the curve (L1-L4). Dr. Chin used a Less Exposure Surgery (LES) approach, addressing the most pronounced section of the spinal curve (L1-L4) by inserting SpineFrontier’s S-LIFT® Lateral Interbody through a single, three inch incision at those levels to straighten out the spine. The surgeons then placed unilateral MISquito® Percutaneous Pedicle Screws to hold the straightened position.

The LES approach through the small incision on the side of the abdomen was low impact and saved Shinel the trauma of an incision through her stabilizing back muscles that could disrupt her strength. It also minimized the surgical trauma and maximized its effectiveness for a rapid and less painful recovery. This approach was especially important because it would allow a teenage girl to resume her daily activities more quickly. The surgeons expected that the thoracic curve would straighten itself over time. After the operation, Shinel already felt straighter and only had minimal superficial pain.

Harisha Buggum, the medical device distributor, had observed several other scoliosis corrections before through the Scotiabank Scoliosis Programme that provided implants at a greatly reduced cost to teenagers with scoliosis. But she had a renewed sense of excitement when talking about Shinel’s operation.

In this surgery, you could see the technology changing the deformity and you could see the spine literally straightening up through the fluoro imaging. It’s good to know technology has turned in the direction so that someone with scoliosis can actually get a correction from Less Exposure Surgery.”

“I’ve never seen that kind of procedure done,” Harisha said, leaning forward and talking energetically, “This was different for us than our day-to-day [procedures]. In this surgery, you could see the technology changing the deformity and you could see the spine literally straightening up through the fluoro imaging. It’s good to know technology has turned in the direction so that someone with scoliosis can actually get a correction from Less Exposure Surgery.”      

Harisha’s excitement over what she observed in the O.R. was just a small window into the many cases that Dr. Chin and his colleagues at the LESS Institute perform on a daily basis in the United States.

“This case is a perfect example of how Less Exposure Surgery can transform a patient’s life,” Chin commented.

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.

Dr. Roger D. Sung First In Colorado to Successfully Implant the Inset Cervical Plate

Dr. Roger D. Sung First In Colorado to Successfully Implant the Inset Cervical Plate from SpineFrontier, Inc. Using the Less Exposure Surgery Philosophy for Segmental Cervical Plating

Beverly, MA – March 2, 2012 ­– SpineFrontier, Inc., a medical device company focused on developing less exposure surgery (LES) technologies, announced today that Roger D. Sung, M.D., an Orthopedic Surgeon in Colorado Springs, CO has successfully implanted the Inset Anterior Cervical Plate while operating at the Spine Center at the Colorado Springs Orthopaedic Group. Performing his first two Inset procedures in one day, the procedures were one and two levels with collapsed discs stabilized by using 5 millimeter Inset plates.

“The new lower profile Inset plate is very easy to place,” said Dr. Sung. “The unique Inset design allows for adjacent level procedures without plate interference.”

Dr. Sung is a graduate of the University of California at San Diego and went on to receive his medical degree and complete his orthopedic surgery residency from the UCLA School of Medicine.  He is a board certified Orthopedic Surgeon and completed his orthopedic surgery fellowship at Case Western Reserve University under the mentorship of Henry H. Bohlman, M.D.  He currently practices at the Spine Center at the Colorado Springs Orthopaedic Group.

About the Inset Cervical Plate

The Inset Cervical Plate System was recently released by SpineFrontier, Inc. The system provides surgeons with a low profile plate design with large graft windows for visibility and anterior graft packing. The pre-angled screw holes make it easy to insert the screws reliably, but also allow the ability to vary the angle of the screws on insertion. The zero-step dual-integrated lock mechanisms with folding wings on the screw head and a mating slot within the plate means there is no secondary locking mechanism that can fail so there is prevention of screw back-out with the Inset plate.

The Inset Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.

About SpineFrontier

SpineFrontier Inc. is a growing medical device company that designs, develops and markets implants and instruments used in spine surgery. The SpineFrontier team is focused on developing innovative technologies and techniques for spinal surgery based on the Less Exposure Surgery (LES) philosophy. The company was founded in 2006 and is headquartered in Beverly, MA.

About Less Exposure Surgery (LES)

“The Less Exposure Surgery philosophy is to use proportionate exposure for maximal effectiveness, to preserve the anatomy, diminish blood loss, surgical time, and exposure to radiation,” said LES Society Course Chairman and Spine Surgeon Kingsley R. Chin, M.D.

Contact

Media: connecting@spinefrontier.com

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Dr. Kingsley R. Chin Successfully Implants New E-LIFT

Dr. Kingsley R. Chin Successfully Implants SpineFrontier’s New E-LIFT Interbody Cage at University Hospital in Tamarac, Florida

Beverly, MA – February 29, 2012 ­– SpineFrontier, Inc., a medical device company focused on developing less exposure surgery (LES) technologies, announced today that Kingsley R. Chin, M.D., an Orthopedic Surgeon at the Institute for Modern and Innovative Surgery (iMIS) in South Florida, has successfully implanted the first E-LIFT interbody cage through an extraforaminal oblique-lateral approach at L4-5. The patient was a 77-year-old female with degenerative spondylolisthesis, severe neurogenic claudication, and back pain.

“The E-LIFT system allowed me to do this surgery through a one centimeter incision with only 30 cc of blood loss, and less than three minutes of live fluoroscopy time. We increased the disc height and foramen with a 12 millimeter E-LIFT PEEK cage, which treated the patient’s stenosis and instability,” said Dr. Chin. “We avoided having to use a lateral decubitus position, which would risk injury to the lumbar plexus had we used a direct lateral approach. Instead, we were able to add posterior LES technologies to decompress and stabilize the lumbar spine without changing the patient position. I think the E-LIFT technique has the potential to be the best approach for interbody fusion from L1-L5.”

Dr. Chin is a graduate of Harvard Medical School and trained at the Harvard Hospitals, including Massachusetts General Hospital in Boston. He is a board certified Orthopedic Spine Surgeon who completed a fellowship specializing in spinal surgery at Case Western Reserve University under the mentorship of Henry H. Bohlman, M.D.  Dr. Chin has published extensively, holds multiple patents, edited textbooks, lectured worldwide on spine surgery, and was an Assistant Professor of Orthopaedic Surgery and Chief of Spine Surgery at University of Pennsylvania Medical School from 2003 to 2007. He founded and currently runs the Institute for Modern and Innovative Spine Surgery in South Florida.

About LES Technology

E-LIFT Extraforaminal Lateral Interbody System is a Less Exposure Endoscopic Surgery (LEES) technology from SpineFrontier, Inc. that adheres to the LES philosophy for spinal fusion. E-LIFT is designed for the goal of spinal stabilization, while minimizing incision size, preserving the facets, and retaining the normal anatomy.

“The E-LIFT technique is based on the principle of distracting the disc space with sequential dilating cannulas to increase the foraminal height. This allows for a more complete discectomy and endplate preparation for fusion,” said Dr. Chin. “Standard lateral access instruments like shavers and curettes are used though the cannula. The bulleted and cannulated E-LIFT PEEK cage further self-distracts the disc space during insertion over a guidewire or through the LESR-O cannula.”

E-LIFT is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SpineFrontier E-LIFT Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine (example: Facet Screw Fixation).

“The E-LIFT system provides surgeons the unique benefits of an effective discectomy and safe interbody delivery without impact to anatomy,” said SpineFrontier’s E-LIFT Product Manager Vito Lore.

About SpineFrontier

SpineFrontier Inc. (www.spinefrontier.com) is a growing medical device company that designs, develops and markets implants and instruments used in spine surgery. The SpineFrontier team is focused on developing innovative technologies and techniques for spinal surgery based on the Less Exposure Surgery (LES) philosophy. The company was founded in 2006 and is headquartered in Beverly, MA.

About Less Exposure Surgery (LES)

“The Less Exposure Surgery (www.les-society.org) philosophy is to use proportionate exposure for maximal effectiveness, to preserve the anatomy, diminish blood loss, surgical time, and exposure to radiation,” said LES Society Course Chairman and Spine Surgeon Kingsley R. Chin, M.D.

Contact

Media: connecting@spinefrontier.com

Dr. S. Craig Meyer First to Successfully Implant the Inset Cervical Plate

Dr. S. Craig Meyer First to Successfully Implant the Inset Cervical Plate from SpineFrontier, Inc. Intended For Segmental Anterior Cervical Fusion Using the Less Exposure Surgery Philosophy

Beverly, MA – February 29, 2012 ­– SpineFrontier, Inc., a medical device company focused on developing less exposure surgery (LES) technologies, announced today that Steven Craig Meyer, M.D., an Orthopedic Surgeon in Columbia, MO has implanted the first Inset Anterior Cervical Plate while operating at the Columbia Orthopaedic Group.

“Inset is a revolutionary plate. It is unique in comparison to other plating options due to its low profile,” said Dr. Meyer. It actually sits inside the disc space and allows easy segmental fixation capability one level at a time.”

Dr. Meyer is a graduate of the University of Missouri-Columbia and went on to receive his medical degree and complete an orthopedic surgery residency at the School of Medicine at the University of Missouri. He is a board certified Orthopedic Surgeon and completed his spine fellowship at the Institute for Spinal Disorders at Cedars-Sinai Medical Center. Dr. Meyer is one of the rare surgeons who completed a fellowship combining orthopedic surgery and neurosurgery. He currently practices at the Columbia Orthopaedic Group in Columbia, MO.

“This [first case] was a challenging revision surgery for adjacent segment disease. Originally, I had planned on performing the decompression above the previous fusion, then plating Inset at each level without removing the previously placed anterior instrumentation. However, I removed it because it obstructed my visualization while trying to decompress. In the future, I anticipate being able to place Inset without having to remove the previous instrumentation in the case of adjacent level degeneration, as long as the previous device does not interfere with decompression,” said Dr. Meyer. “Inset will enable surgeons to perform the same surgery with less time and exposure, and not have to worry about finding instrumentation to remove a plate that was placed 10-15 years ago.”

About the Inset Cervical Plate

The Inset Cervical Plate System was recently released by SpineFrontier, Inc. The system provides surgeons with a low profile plate design with large graft windows for visibility and anterior graft packing. The pre-angled screw holes make it easy to insert the screws reliably, but also allow the ability to vary the angle of the screws on insertion. The zero-step dual-integrated lock mechanisms with folding wings on the screw head and a mating slot within the plate means there is no secondary locking mechanism that can fail so there is prevention of screw back-out with the Inset plate.

“The new ultra-low profile Inset ACP is an exciting improvement in segmental spine surgery,” said SpineFrontier’s Inset Product Manager Mike Drnek.

The Inset Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.

About SpineFrontier

SpineFrontier Inc. is a growing medical device company that designs, develops and markets implants and instruments used in spine surgery. The SpineFrontier team is focused on developing innovative technologies and techniques for spinal surgery based on the Less Exposure Surgery (LES) philosophy. The company was founded in 2006 and is headquartered in Beverly, MA.

About Less Exposure Surgery (LES)

“The Less Exposure Surgery philosophy is to use proportionate exposure for maximal effectiveness, to preserve the anatomy, diminish blood loss, surgical time, and exposure to radiation,” said LES Society Course Chairman and Spine Surgeon Kingsley R. Chin, M.D.

Contact

Media: connecting@spinefrontier.com