THE ELEVEN BEST NEW SPINE TECHNOLOGIES FOR 2014 (Orthopedics This Week) …you can read the selection process and judges at end of article.
Here are the 11 best new spine technologies for 2014 arranged in alphabetical order by category:
Category: Biomaterials and Biologics
One Winning Technology
MAGNIFUSE II
Company: Medtronic Spinal
Inventors: G. Wei, K. Behnam, N Forsyth, J. Winterbottom, J. Beisser, T. Boyce, M. Attawia, C. Richards, L. Shimp, S. Berven, R. Betz, M. O’Brien, A. Shelokov, R. Cohen, A. Vaccaro, S. Boden, H. Sandhu, D. Sybert, M. Gupta
Engineering Team: Kerem Kalpakci, Kelly Schlachter, Suneeth Mohan, Guobao Wei, Susan Drapeau, Dan Shimko, Bill McKay
MAGNIFUSE II DBM bone graft is assembled at the time of use by the clinician. The clinician is able to combine the provided demineralized allograft bone with recovered autograft, and then pack the combination of tissues into a unique, self-contained, resorbable mesh bag using the provided disposable funnel and plunger. The surgeon can then place the fully contained construct into bone voids. The ability to add autograft into the resorbable mesh is a significant advantage of the MAGIFUSE II DBM bone graft as it places patient autograft in direct contact with the highly inductive MAGNIFUSE DBM tissue fibers. The MAGIFUSE II DBM bone graft kit provides enough material to make and deliver bilateral constructs for either single or two level fusion cases.
To further improve on the MAGNIFUSE device, MAGNIFUSE II DBM bone graft was developed and launched. With the addition of MAGNIFUSE II DBM bone graft to the market place, clinicians can now extend robust containment to their autograft as well by use of the provided PGA mesh containment bag. The ability to co-locate autograft and allograft has always been desirable, but no commercial offering has achieved the level of containment and ease of placement made available by MAGNIFUSE II DBM bone graft.
Category: Cervical Care
One Winning Technology
Zip Surgical Skin Closure
Company: ZipLine Medical, Inc.
Inventors: Amir Belson, M.D., Eric Storne, Eric T. Johnson, Robert R. Ragland, Phillip C. Burke, Luke Clauson
Engineering Team: Kei Ichiryu, Zach Kimura, Alan Schaer, Daren Stewart, Melissa Guerrero, Jeremy Edinger, Emily Cullinan, Lori Munoz, Julie Ridgeway, John Tighe, Eric Storne
The Zip Surgical Skin Closure provides a non-invasive alternative to staples, sutures and glue for surgery and lacerations. It is used by surgeons (orthopedic, general, cardiac, ob/gyn, plastic/reconstructive, dermatology) and emergency department physicians, and because of the device’s ease of use, no suturing skill is required so the closure task using the Zip device can be delegated to a physician’s assistant or RN.
This Zip is applied to intact skin immediately surrounding a surgical incision, and is placed at the end of the procedure, when the skin layer is to be closed. It replaces conventional means of skin closure such as staples, sutures and glue. It utilizes a strong yet skin-friendly hydrocolloid adhesive that lasts for 14 days, and is easily removed. The incision is closed by sequentially tightening a series of ratcheting straps, similar to “zip-ties,” to produce the desired incision closure and tension.
The Zip consists of biocompatible polymeric materials, including hydrocolloid adhesive, polyurethane monofilm, nylon injection-molded tensioning mechanism and polyester force-distributing plates. It is a single-use device and is provided sterile in a sealed pouch suitable for aseptic transfer to a sterile field.
Category: Diagnostic and Imaging
Three Winning Technologies
Lessray
Company: SafeRay Spine, LLC
Inventor: Rob Isaacs, M.D.
Engineering Team: Randall Campbell, Samuel Johnson, Ph.D., David Skwerer, MEng.
Lessray is an image enhancement platform designed to take low quality, low radiation images and improve them to look like conventional full dose images. It uses proprietary image processing to post-process low dose/pulsed images, improving clarity and contrast to provide a clinically valuable image.
Lessray interfaces directly with the fluoroscope. The captured low dose images created by the fluoroscope are transmitted to the Lessray computer where the images are enhanced and then displayed on the Lessray monitor in real time. Further, as a result of the way the software acts upon the image, new radio dense metal tools and implants added to the field can be rendered partially radiolucent or made to disappear and reappear, allowing the physician to better view their relationship to the underlying anatomy.
Fluoroscopic radiation has been identified for decades as a potential cause for a host of medical problems and is a well-established cause for cancer, cataracts, cardiovascular disease, and mental retardation in newborns, prenatal death, and more. It has been widely estimated that 2% of all the newly diagnosed cancers in the U.S. are as a result of medical imaging. While physicians are expected to use the lowest radiation setting possible, the image quality of ultra-low radiation imaging becomes too grainy for safe use during an X-ray dependent procedure. Lessray can make the lowest radiation images on a fluoroscope appear similar to a full dose, conventional X-ray. In fact, in many instances, more information about the underlying anatomy is given to the physician.
Scolioscreen
Company: Spinologics, Inc.
Inventors: Mark Driscoll, P.Eng., Ph.D., Stefan Parent, M.D., Ph.D., Hubert Labelle, M.D., and Jean-Marc Mac-Thiong, M.D., Ph.D.
Engineering Team: Mark Driscoll, P.Eng., Ph.D.
The Scolioscreen was developed as a medical device to be used in combination with a smartphone for the early detection of spinal deformities such as scoliosis.
The Scolioscreen is made from a medical grade thermoplastic rubber for comfortable and safe contact with patient skin. The Scolioscreen is also sized to effectively hold all smartphones, with or without a protective case. That is, the novel expandable walls of the Scolioscreen device enable it to securely hold and support any smartphone.
Mobile smartphones are equipped with inclinometers enabling them to acquire angular clinical measures. The adoption of smartphone in the practices of medical professionals is quickly growing. The Scolioscreen has been developed in conjunction with a smartphone APP to enable the measure of the angle of trunk inclination (ATI) which is a clinical index used for the early detection of spinal deformities.
G-Arm Multi-Plane Surgical Imaging
Company: Whale Imaging
Inventors: Sean Zhu, Shiyu Wei and Jun Zhang
Engineers: Feng Zhou, Yang Li, Liu Cao, Chunpeng Zhu, Xinghong Sun, Chunlei Tian, Yixiu Wang
What if you no longer have the challenge of shifting between AP/LT views? With the G-Arm’s X-Beam advanced digital platform the surgeon can confidently perform procedures more accurately and in less time than ever before. The unique system platform provides bi-plane views and allows both AP/LT anatomy to be viewed live and simultaneously at up to 25fps on each plane. Right and left monitor views are real time, giving you unprecedented ability to carry out the procedure accurately, quickly and confidently.
Here are the key attributes of this innovative G-Arm:
- Lower dose: Fewer corrective exposures means cumulative radiation can be minimized for patient and staff.
- Less infection risk: Eliminating the need to alternate the detector plane decreases disruption of the sterile field
- Reduced time: Faster placement due to live twin plane views decreases time lost moving the arm and repositioning between
- AP and lateral views.
- Greater accuracy: X-Beam technology enables better precision. Better placement makes revision is less likely.
Category: Minimally Invasive Spine Care
Two Winning Technologies
Smart Strap
Company: 109 Design
Inventors: Sebastian Monzon, Ellen Su, Levi DeLuke
Engineering Team: Levi DeLuke, Ellen Su, Sebastian Monzon
The young inventors (see photo) that comprise 109 Design developed a system to improve adolescent scoliosis treatment. Their invention combines a medical device which gathers data on each patient’s treatment using a software platform that sends that patient’s data to doctors, the patients themselves, and parents. That feedback capability incentivizes these young patients to wear their brace and keep it tightened as prescribed by their physician.
The hardware consists of a “smart” strap that replaces the existing straps of a scoliosis back brace. These straps can measure how long and how tightly the braces are being worn and then sends the real-time data to a smartphone application using Bluetooth Low Energy.
As most parents and physicians of adolescents with scoliosis can attest, compliance, defined as the brace wear time, is a big issue. That alone constitutes the most significant challenges for successful bracing treatment. Researchers who’ve studied this report that increased compliance leads to better outcomes, in other words lower curve progressions.
And that, of course, is the whole point behind Design 109’s smart strap.
Here’s how the system works. A smartphone application downloads the data collected by the smart strap to the Internet. From there, patients, parents, and doctors can access it. The system compares actual time and tightness that the brace is being worn with the doctor’s prescriptions. Parents and patients can see a quick overview of brace wear. Parents can set incentives to encourage their children to wear the brace as prescribed. Doctors, of course, also see the data via a web application which they can use to fine tune the treatment prescriptions in real time.
S4 Element MIS
Company: Aesculap, Inc.
Inventors: Peyman Pakzaban, M.D., Scott Webb, D.O.
Engineering Team: Thomas Hur, Andrew Dauster
S4 Element MIS is all about direct visualization through an endoscope and allows the surgeon pure percutaneous posterior pedicle screw fixation. Here’s how:
First, you can better see what you are doing and do so with much less radiation exposure. Why? The endoscope. Many surgeons rely heavily on C-arms to compensate for the lack of direct visualization, especially during screw insertion and rod passage. Because of this, they are exposed to radiation for considerably longer periods especially if they are new to MIS.
With S4 Element MIS the surgeon can visualize during rod passage, confirm rod delivery, position, and length, and, therefore, trouble shoot challenges and minimize guesswork (i.e., soft tissue impeding starting set screw, impeding rod delivery, confirmation of downtube proper reattachment, etc.) associated with MIS. And, of course, there’s that reduction in radiation exposure.
Finally, the S4 Element MIS downtube has industry leading rescue instrumentation and technique that enable in-situ downtube reattachment to the screw in the simplest, possible way. This robust instrumentation and technique eliminates the concerns of open conversion, builds confidence, and provides a powerful arsenal in the surgeon’s bag.
Category: Thoraculumbar Care
Four Winning Technologies
MySpine Patient Matched Technology
Company: Medacta International SA
Inventors: Prof. Claudio Lamartina, M.D. I.R.C.C.S., Kai-Uwe Lewandrowski, M.D., Meinrad Fiechter, Francesco Siccardi
Engineering Team: Alberto Lipari
MySpine Patient Matched Technology utilizes patient CT scans and unique 3D planning tools to create patient-specific anatomical drill/screw placement guides to simplify pedicle screw placement during spine surgery.
A low-dose protocol for collecting patient CT scans has been identified and validated. Adapted from the 3D reconstructed patient’s vertebrae, a pre-surgical planning document is prepared, allowing the screw size, trajectory and position to be defined by the surgeon. The entire process is collaborative with the treating surgeon, as traditional CAD (computer aided design) software is utilized to demonstrate initial screw position, and then modified with surgeon input reflecting specific preferences designed to improve treatment outcomes. After surgeon approval of the pre-operative planning, the guides are designed and state-of-the-art 3D Laser Printing equipment is used to create an anatomic 3D model of each affected spinal vertebra and the corresponding guide. The drill guides are designed to accommodate all instruments necessary for intraoperative pedicle identification and screw insertion. The MySpine technology in most instances significantly reduces the need for intraoperative imaging and exposure to both surgeons and patients.
ARC Pedicle Screw System
Company: NLT SPINE
Inventors: Tzony Siegal, Oded Loebl, Didier Toubia
Engineering Team: Oded Loebl, Moti Altarac
The ARC pedicle screw system is a pedicle screw and delivery instrument system intended for posterior fixation in the thoracolumbar spine. It is comprised of two sub-sets: the single-use ARC percutaneous pedicle screw, consisting of a full array of lengths and diameters, and a set of reusable instruments (the ARC pedicle screw delivery system) used for screw implantation. The screws are cannulated for over-the-wire, percutaneous insertion and made of titanium alloy. The screws have bendable tips for increasing the pullout strength of the screw from the bone. The tip bending is completely reversible for removal/revision of the screw, if necessary.
Tiger Express
Company: SafeWire, LLC
Inventors: Wyatt Geist and Choll Kim, M.D.
Engineer: Wyatt Geist
The Tiger Express Pedicle Access Needle with Broach is designed to improve the surgeon’s workflow, depth accuracy, and reduce the need for fluoroscopy when accessing the pedicle. First it is an extremely strong design, which will allow the surgeon to access the pedicle no matter how hard the cortical bone might be.
Second, it incorporates a broach that will prepare the first 15mm of the pedicle with a 4.4mm hole for easier insertion of MIS screws. The design rational was to leave the last 5mm of bone in the pedicle un-broached. The last 5mm is usually more cortical and should result in good fixation since it will be un-broached and un-tapped.
Third, a depth stop is incorporated to aid the surgeon to achieve a set depth. Lastly, it incorporates an atraumatic mechanical back-out feature. No longer will surgeon have to struggle removing access needles, it is removed simply and coaxially, while putting almost zero torque on the guidewire, reducing the chance of accidently removing the guidewire.
ReLeaf Anesthetic Delivery Catheter
Company: Vital 5, LLC
Inventors: Frank M Phillips, M.D., Kern Singh, M.D., Thomas Wade Fallin, Jean-Sebastien Merette, Patrick Michel White
Engineering Team: Thomas Wade Fallin, Jean-Sebastien Merette, Patrick Michel White
Vital 5’s invention is a dual function directional analgesic infusion catheter and wound drainage system. While continuous anesthetic infusion to the surgical site in the immediate post-operative period has been clinically proven to provide significant improvements to pain management, it is not compatible with the millions of surgical cases where a wound drain is prescribed.
Vital 5’s innovation solves that problem. The system provides a continuous local anesthetic infusion while also providing an effective wound drain function. The name of the invention is the ReLeaf.
Because of the inherent conflict between infusing local anesthesia and allowing the wound to drain, most physicians avoid a “local” in spine with exposed dura because of concerns for inadvertent spinal nerve blockade. The ReLeaf solves this problem with a barrier technology to minimize local anaesthetic contact with exposed neural elements. The clinical applications for the Vital 5 ReLeaf include any invasive surgical procedure, including spine, orthopedic, cardiothoracic, plastic, general, obstetrics and gynecological procedures.
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The companies who submitted winning technologies were: 109 Design; Aesculap, Inc.; Medacta International SA; Medtronic, Inc.; NLT SPINE; SafeRay Spine, LLC; SafeWire, LLC; Spinologics, Inc.; Vital 5, LLC; Whale Imaging, Inc. and ZipLine Medical, Inc.
This year’s scores included a virtual tie so we have 11 wining companies and, we note, a healthy and welcome plurality of young innovative companies.
This annual award rewards inventors, engineering teams, surgeons and their companies who’ve created the most innovative, enduring and practical products in 2014 to treat back pain. To win the Orthopedics This Week Best New Technology Award for spine care, a new technology must meet the following criteria:
- Be creative and innovative.
- Have long term significance to the problem of treating the diseases of the spine. Does this technology have staying power?
- Solve a clinical problem. To what extent does this technology solve a current clinical problem or problem that is inadequately solved today?
- Does it have the potential to improve standard of care?
- Is it cost effective?
- I would use it.
Our panel of surgeons score every submission on a scale of 1 to 5 (5 being the highest score) for each of the above criteria.
We and our panel of surgeons were impressed that inventors—despite ever growing hurdles to innovation and entrepreneurism in spine—still managed to create a solid group of more than 40 new products to submit for the 2014 Orthopedics This Week Spine Technology Awards.
We offer our thanks and deep appreciation to the engineering teams, surgeon inventors and the following companies for submitting their best ideas this year:
109 Design
Aesculap, Inc.
AlignMed
Amendia, Inc.
Benvenue Medical, Inc.
BioStructures, LLC
CareFusion Corporation
Centinel Spine, Inc.
Exactech, Inc.
Expanding Orthopedics, Inc.
Icoteg AC
K2M, Inc.
Mainstay Medical Ltd
Medacta International SA
Medtronic Spinal
MI4 Spine LLC
Mighty Oak Medical
NLT SPINE
NuVasive, Inc.
Orthobion Gmbh
Orthopedic Sciences, Inc.
Renovis Surgical Technologies, Inc.
SafeRay Spine, LLC
SafeWire, LLC
Shanghai Sanyou Medical
Spinal Simplicity, LLC
Spine Wave, Inc.
Spinologics, Inc.
Stryker Spine
Synergy Disc Replacement, Inc.
Trinity Orthopedics, Inc.
Vertebral Technologies, Inc.
Vital 5, LLC
Wenzel Spine, Inc.
Whale Imaging, Inc.
Zimmer Spine
The Judges
Our intrepid and detailed panel of surgeon judges included:
- Neel Anand, M.D.: Dr. Anand is the Director of Orthopaedic Spine Surgery at the Cedars-Sinai Institute for Spinal Disorders in Los Angeles and a frequent contributor to such peer-reviewed publications as the Journal of Spinal Disorders, Journal of Orthopedic Trauma, Spine and the Journal of Bone and Joint Surgery.
- Scott Blumenthal, M.D.: Dr. Blumenthal is a leader in spinal arthroplasty and currently serves as a clinical assistant professor of orthopedic surgery at the University of Texas Southwestern in Dallas and is an ongoing contributor to the first non-profit foundation created for arthroplasty patients. He also currently serves as a spine consultant for the Dallas Mavericks.
- Alan Hilibrand, M.D.: Dr. Hilibrand is a Professor of Orthopaedic Surgery and Neurosurgery, as well as the Director of Medical Education for the Department of Orthopaedic Surgery at the Rothman Institute and Jefferson Medical College.
- Daniel Riew, M.D.: Dr. Riew is the Mildred B. Simon Professor of Orthopedic Surgery; Dr. Riew is a professor of neurological surgery and Chief of the Surgical Spine Center and Director of the Cervical Spine Institute at the Washington University School of Medicine.
- Rick Sasso, M.D.: Dr. Sasso is a founding member, and the president of Indiana Spine Group. He is the co-medical director of the St. Vincent Spine Center, and a clinical associate professor and chief of spine surgery at the Indiana University School of Medicine, Department of Orthopaedic Surgery.