20 minimally invasive spine products to know | 2018

Spinal technology is evolving rapidly around minimally invasive techniques to perform more precise, less disruptive procedures. Device companies big and small aim to advance the field through innovative implant materials, techniques and technology that will make procedures more precise and patient-specific.

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The medical technology business of ZEISS offers a comprehensive line of surgical microscopes and loupes that uncompromisingly enhance visualization during spine surgery. ZEISS supports spine surgeons in seeing more by ensuring optical precision, flexibility, fast OR setup and ease of use for surgeon, assistant and OR staff.

Here are 20 minimally invasive spine device products to know.

AnchorKnot (Anchor Orthopedics XT). The AnchorKnot Tissue Approximation Kit is designed for patients undergoing herniated disc repair. The kit facilitates suture access in difficult-to-reach locations and is compatible with minimally invasive surgical techniques. In February 2017, Scott Blumenthal, MD, of Texas Back Institute in Plano, performed the first discectomy procedure in the U.S. using the AnchorKnot technology.

BACS Surgical Planner (K2M). The BACS Surgical Planner is a technology platform that helps the surgeon measure and document skeletal parameters to select the right implants and treatment for each individual patient. Surgeons can also simulate corrections with the program and examine common osteotomy techniques. In May, K2M achieved FDA clearance for the BACS Patient-Specific Module for the platform, allowing surgeons to create pre-contoured rods, rails and templates to match their preoperative plan.

Coflex (Paradigm Spine). Paradigm Spine's coflex is a non-fusion alternative to stabilize the spine after surgical decompression. The titanium metal implant is designed to help maintain normal foraminal height and motion in the spine and can be used during an inpatient or outpatient procedure. According to the FDA clinical study, patients who undergo surgical procedures with coflex report earlier relief of spinal stenosis symptoms, 40 percent shorter hospital stay compared to fusion and higher patient satisfaction; two years after surgery, 94 percent of coflex patients were satisfied with outcomes, compared to 87 percent of fusion patients.

DTRAX (Providence Medical Technology). In May, Providence Medical Technology achieved FDA clearance for the DTRAX Spinal system, indicated for degenerative disc disease patients undergoing posterior cervical fusion. The system is a sterile-packaged, single-use set of instruments for cervical fusions and includes a facet joint access instrument, lateral mass decortication trephine and mallet as well as the cannula, decortication burr and bone graft tamp. The largest instrument is less than 1 cm in diameter, allowing for use in a variety of minimally invasive procedures.

Coalition MIS (Globus Medical). Coalition MIS is designed for anterior cervical discectomy and fusion procedures. The curved anchor fixation is delivered inline to the disc space with instruments around the same size as the spacer. When the device is used with two screws, its FDA cleared for standalone applications at two levels.

iFuse (SI-BONE). Surgeons have used the iFuse Implant System for minimally invasive sacroiliac joint fusions in more than 30,000 procedures worldwide. In March, the company published three-year data from a U.S. randomized controlled trial as well as a prospective multicenter trial showing quality of life achievement and patient satisfaction after undergoing surgery with the iFuse system. Payers are also seeing the value of minimally invasive SI joint fusions, including most recently the Blue Cross Blue Shield Association, which raised its clinical evidence rating for the procedure.

Illico MIS Posterior Fixation System (Alphatec Spine). The Illico MIS Posterior Fixation System aims to reduce complications, recovery time, pain and blood loss for patients undergoing minimally invasive spine surgery. The Illico MIS is a percutaneous system with comprehensive screw and rod delivery options customizable to the surgeon's preferred technique. The platform's guidewire management instruments are designed for surgeon control and the single-step extender interface is designed for easy attachment and removal, to save time in the operating room.

Levo (Mizuho OSI). Mizuho OSI introduced the Levo Head Positioning System in October 2017. The system uses electro-mechanical technology for surgeons to control the patient's head positioning during surgery. The technology's interface supports initial head positioning and surgeons can make cervical corrections throughout the procedure. Levo's interchangeable modules support patients who use a skull cap or face pillow for support during the procedure. Once integrated into the operating room, Levo can improve efficiency of the procedure and reduce patient time in the OR.

M6 (Orthofix). In March, Orthofix acquired Spinal Kinetics and its M6 artificial disc replacement technology. The disc is designed to replicate the patient's natural anatomy and incorporates an artificial nucleus made from polycarbonate urethane. The disc also has a woven fiber annulus made from polyethylene and titanium outer plates with kneels to anchor the disc to bone. M6 aims to give patients a more natural range of motion while providing long term stability in the spine.

Mahe Spine Emergency Screw Removal System (Mahe). Mahe Medical partnered with Amazon Business Professional Healthcare to be among the first spine companies to sell products on Amazon. Mahe's Spine Emergency Screw Removal System is now available on Amazon, sold at 20 percent less than competing systems due to the flattened supply chain. The Mahe Spine Emergency Screw Removal Kit is designed to remove broken or stripped screws without additional hardware or kits, and the system can remove a screw regardless of the manufacturer.

Mazor X (Mazor). Mazor X is a robotic guidance system that combines advanced software, robotic technology and instrumentation for a more precise minimally invasive spinal procedure. Mazor X is the third generation of robotic technology and was used in more than 1,000 cases across 50 hospitals in the U.S. during its first year on the market. The technology provides preoperative and intraoperative surgical planning as well as offers robotic-guidance for pedicle screw placement.

Mobi-C (Zimmer Biomet). The Mobi-C was designed in France and first implanted in November 2004. The artificial disc, made with a mix of cobalt, chromium and molybdenum as well as metal plates sprayed with hydroxyapatite, earned FDA approval in August 2013 and remains the only artificial disc to achieve two-level clearance. The Mobi-C is designed for disc self-adjustment and can move with the spine to facilitate natural motion. The procedure does not require bone chiseling and aims to preserve as much of the patient's vertebrae as possible.

NuVasive MAS TLIF (NuVasive). MAS TILIF is a minimally invasive transforaminal lumbar interbody fusion technique with a pedicle-based retractor that facilitates maximum visualization and access to the surgical site through a modular screw construct. The complete procedural solution comprises access, fixation, biologics and computer assistance. Surgeons use a small incision and approach the spine from one side of the back, leading to less muscle disruption and faster recovery times.

PowerEase (Medtronic). Medtronic launched PowerEase in April 2012 as a system of electronic instruments designed for reconstructive spine surgery. The system is compatible with CD Horizon Solera Spinal System and TSRH 3Dx, as well as integrated with other Medtronic technologies. PowerEase is used for drilling, tapping and driving implants during spine surgery for both open and minimally invasive procedures. The system demonstrates 51 percent less time required for tapping the pedicle and 55 percent less time for plating the pedicle than manual instruments based on biomechanical testing.

Rialto SI Joint Fusion (Medtronic). The Rialto SI Fusion System is designed to stabilize the sacroiliac joint and promote fusion. The system comprises cylindrical threaded devices that aim to enhance fusion, offered in multiple lengths that accommodate each patient's anatomy. During the procedure, surgeons take an anterior approach to the surgical site and often place two devices to provide stability and promote fusion.

SImmetry (RTI Surgical). In March 2018, The Spine Journal published a study showing the SImmetry Sacroiliac Joint Fusion System, a minimally invasive approach to SI joint fusion, reporting the system's joint fixation effectively reduces SI joint range of motion. SImmetry is the only minimally invasive SI joint system that uses proprietary decortication technology to facilitate bone fusion. In January 2018, RTI Surgical acquired Zyga Technology and the SImmetry system.

UNiD (Medicrea). In June, Medicrea received FDA clearance for its UNiD cage technology, the first patient-specific spinal cage to earn approval. The company designs 3D printed titanium devices using its IB3D predictive analytics model to develop an implant fitted to the patient's natural anatomy. To date, more than 2,400 surgeries have been performed using UNiD, which also includes patient-specific rods that achieved FDA clearance in 2014.

Viper Prime System (DePuy Synthes). The Viper Prime System is a percutaneous pedicle screw placement technique that eliminates guidewires, Jamshidi needles and pedicle preparation instruments. The system allows surgeons to target pedicles and insert screws in a single instrument pass, using a stylet fully controlled by the screwdriver and new tip design. Viper Prime aims to improve procedure efficiency and reduces the instrument set from six to two trays. In one study, the Viper Prime reduced pedicle screw insertion time by 33 percent when compared with traditional techniques.

VariLift-C (Wenzel Spine). The VariLift-C is a standalone expandable interbody fusion device that expands in situ, which eliminates plates and screws during the procedure. The implant's design allows for extensive graft material use after implementation and it has a broad FDA clearance for use with or without supplemental fixation. The device is designed for shorter surgical times and can be used at one level, bilaterally or unilaterally.

OPMI PENTERO 800 (Zeiss). OPMI PENTERO 800 surgical microscopes include advanced apochromatic optics and two-channel xenon illumination to provide visual clarity during procedures. The technology comprises an intuitive user interface for direct surgical microscope access as well as a touch screen that delivers patient data, preset configurations and video recording to the user. The system is designed to minimize the physical strain on surgeons, and its intelligent ergonomic properties can enhance handling, with the potential to streamline surgical workflow.

 

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