eCential Robotics Receives FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device

eCential Robotics has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an innovative Spine Navigation and Robotic-Assistance Device. This device provides a new, advanced solution for planning and instrumenting spinal fusion procedures.

This spine robot was developed by eCential Robotics in the framework of a collaboration with DePuy Synthes (DPS), The Orthopaedics Company of Johnson & Johnson. DPS will leverage its extensive reach and expertise to bring this innovative solution to market.

This milestone achievement highlights eCential Robotics’ unique expertise in the field of surgical navigation and robotics, reaffirming its dedication to supporting and advancing the healthcare system.

“This additional FDA clearance is a testament to our relentless pursuit of innovation and excellence in the field of surgical robotics and navigation,” said Clément Vidal, CEO at eCential Robotics. “We look forward to continuing to deliver cutting-edge solutions that enhance surgical precision and patient outcomes.”

eCential Robotics will continue to focus on developing the commercial activities of its unique Open eCential Platform in the U.S. and partnering with implant manufacturers, tech companies to expand the range of Applications available on the Platform.

Source: eCential Robotics 

Innovative Medical Products & Curexo Inc. Announce Strategic Partnership

Innovative Medical Products, Inc. (IMP) and Curexo Inc. announce global strategic distribution partnership combining Curexo’s artificial joint surgical robot, CUVIS-joint, with IMP’s industry-leading De Mayo D2® Knee Positioner.

IMP, an innovator in surgical patient positioning devices, announced its entry into a nonexclusive OUS distribution agreement with Curexo, Inc., developers of the world’s first fully automatic surgical robot. Under the distribution agreement, Curexo will include a De Mayo D2 Knee Positioner, a De Mayo Universal Distractor® 2.0, and an IMP Sterilization Case, along with the implementation of the CUVIS-joint robot, in hospitals outside the U.S. and around the world. IMP will continue its independent sales distribution channel within the U.S. and globally.

“We are excited to foster this relationship with Curexo and enhance our strategic initiative to provide surgical patient positioners to hospitals and surgeons worldwide. The De Mayo D2 Knee Positioner, along with the De Mayo Universal Distractor, is ideal for stabilizing the knee joint during robotic knee replacement surgery, and partnering with the next-generation CUVIS-joint robotic platform allows both organizations to provide the best care to the patients,” said Mike Reilly, Chief Commercial Officer of IMP.

Jae Jun Lee, CEO of Curexo, Inc., said, “The De Mayo D2 Knee Positioner, along with the De Mayo Universal Distractor with the CUVIS-joint, has proven to be the best combination for successful robotic surgery in 16,000+ cases of TKA surgery to date. Through this global strategic distribution partnership, we expect to establish a stable distribution relationship with IMP in all regions where we supply CUVIS-joint and to develop new technology that is more suitable for our robotic surgery of CUVIS-joint.”

“The De Mayo D2 Knee Positioner and the De Mayo Universal Distractor have demonstrated to be extremely valuable tools for orthopedic surgeons. Pairing those tools with a state-of-the-art robot like Curexo’s CUVIS joint has provided the surgeon an unmatched experience while improving patient care. I’m excited about this partnership and look forward to working with the talented Curexo team,” said Rich Larkin, Chief Operating Officer of IMP.

Source: Innovative Medical Products

Curexo and Motusium Announce Partnership to Enhance Robotic Medical Rehabilitation

Motusium announces partnership with Curexo. This partnership will see Motusium become a key player in the U.S. expansion of Curexo’s acclaimed product, Morning Walk, a gait rehabilitation robot.

Curexo, founded in 2006 and based in Seoul, South Korea, specializes in the development of medical robots, including artificial joint surgical, spine surgical, and gait rehabilitation robots. With its strong foothold in the medical robotics sector, Curexo has been a driving force in technological advancements within the medtech industry. The partnership focuses on the Morning Walk, a rehabilitation robot that stands out in Curexo’s impressive lineup of medical solutions.

Motusium’s collaboration with Curexo represents a significant step in broadening the accessibility of advanced rehabilitation technologies in the United States. By integrating Morning Walk into its array of rehabilitation offerings, Motusium aims to revolutionize the approach to gait rehabilitation, making cutting-edge technology readily available to patients in need of advanced recovery methods.

This partnership aligns with Motusium’s commitment to utilizing AI and robotics in enhancing patient care, marking a new chapter in the company’s mission to redefine rehabilitation solutions. With Curexo’s Morning Walk, Motusium is set to further its impact in the U.S. healthcare market, bringing innovative solutions to the forefront of patient rehabilitation.

Source: Motusium

GE HealthCare Announces Collaboration with DePuy Synthes

GE HealthCare (Nasdaq: GEHC) has entered into a distribution agreement with DePuy Synthes*, the Orthopaedics Company of Johnson & Johnson, to bring GE HealthCare’s OEC 3D Imaging System, in conjunction with DePuy Synthes’ extensive product portfolio, to more surgeons and patients across the United States. This new collaboration demonstrates GE HealthCare’s ongoing commitment to bring exceptional imaging technologies to clinicians providing patient care through the practice of some of healthcare’s most complex spine procedures today.

The spine is a crucial structure to the human body and highly complex in its composition of muscles, bones, tendons, ligaments, and sensitive nerves. Injuries or deformities of the spine can affect any appendage of the body and significantly restrict mobility as well as reduce quality of life as a result. Visualization and imaging are critical to helping achieve accurate diagnosis as well as treatment in the face of such complexity to ensure the most optimal patient outcome.

GE HealthCare’s OEC 3D Imaging System was designed to increase surgical imaging precision and efficiency to further the 3D imaging experience in surgical suites practicing spine procedures every day. The OEC 3D surgical imaging C-arm is a mobile CBCT imaging solution that works to seamlessly enable intraoperative 3D volumes and 2D high-definition imaging while covering a large anatomical field of view. With precise 3D volumetric images and familiar OEC 2D imaging capabilities, the OEC 3D C-arm also includes features for analyzing images, noise reduction, interoperative review, and seamless workflow to help clinicians see a broader picture.

With demand for minimally invasive surgical procedures continuing to grow and ambulatory surgery centers performing more than half of all outpatient procedures in the United States1, providers need efficient imaging capabilities. This new agreement will help enable both companies to better serve surgeons and address the complex needs of their patients and a wide range of procedural needs in spine.

“We know that GE HealthCare’s OEC 3D is a game-changer for clinicians today – from its large field of view and open platform to high-quality reconstructed 3D images,” said Phil Rackliffe, President & CEO for GE Healthcare’s Image-Guided Therapies business. “Through this new collaboration with DePuy Synthes, we’re excited for the opportunity to bring this technology to more spine practices in acute to outpatient settings knowing OEC 3D provides precise and efficient imaging so that surgeons can stay focused on what matters most, providing quality patient care.”

* DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.

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1 https://www.healthcarefinancenews.com/news/ambulatory-surgery-centers-compete-hospitals-outpatient-dollars

Source: GE HealthCare

Globus Medical Receives FDA Approval for its REFLECT™ Scoliosis Correction System

Globus Medical, Inc. has announced that the REFLECT™ Scoliosis Correction System has been granted approval from the US Food and Drug Administration, as the company’s first humanitarian device. REFLECT™ is designed to correct progressive scoliosis in young patients while preserving motion, maintaining stability, and allowing for future modulated growth.

Unlike rigid metal rods for fusion, REFLECT™ uses a flexible, durable cord to harness the power of innate patient growth for correction. The flexible cord is tensioned on the convex side to control the curve, while allowing growth on the concave side. The implants may be inserted using a minimally invasive approach through a few small incisions between the ribs.

“Treating scoliosis in the growing spine presents challenges related to reduced spinal mobility,” says Dr. Juan C. Rodriguez-Olaverri, board-certified orthopedic surgeon and Director of Pediatric Spinal Deformity Surgery and Early Onset Scoliosis at NYU Langone. “REFLECT™ is an exciting development for curve correction that preserves freedom of motion in these young patients, and employs their own remaining growth to help repair the spinal curvature without the need for fusion.”

Kelly Baker, Senior Vice President, Regulatory and Clinical Affairs at Globus Medical, commented, “REFLECT™ has been available internationally for several years, and Globus Medical is very excited to make this system available to patients in the United States. This innovative solution highlights our commitment to addressing the clinical needs of the growing spine and improving the quality of life in these children. It is the latest advancement in scoliosis treatment that provides a non-fusion option for patients and their parents, as they consider the best treatment plan for their lifestyle and goals.”

Source: Globus Medical

Dr. Michael Gallizzi Performs 200th Robotic Surgery with ExcelsiusGPS®

Robotic and endoscopic spine surgeon, Dr. Michael Gallizzi, one of newest additions to The Steadman Clinic’s highly decorated and elite surgical team, performed his 200th robotic surgery on April 4th. It was less than one year ago—April 19, 2022—that Dr. Gallizzi completed his 100th robotic surgery reaching that milestone less than a month after joining the Steadman team, following a very successful practice in the nearby Denver area.

Needless to say, it’s been a very busy and extremely productive first year for Dr. Gallizzi in Vail as he has had over 100 patients experience the benefits of his groundbreaking robotic procedures.  

What has been the major impetus behind this surge in robotic and minimally invasive spinal procedures?

“The biggest thing—especially when you’re revising previous constructs or someone’s previous fusion—is that you have the ability to build off their old surgery and then add the new surgical components,” continued Dr. Gallizzi. “Being able to preoperatively plan all the different aspects of the surgery, line up the screws or implant them exactly where they need to be is an advantage when you use the robotic tool. So it all becomes a homologous construct for the patient. Without robotics, this would be extremely difficult even in the best hands, but with robotics it has become something that is more reliable and reproducible to allow patients that have had previous surgeries to have improved outcomes. Overall, the enthusiasm around having a robotic procedure, the clinical outcomes and the patients’ recovery has been tremendously positive.”

One of the big selling points on robotic spinal procedures is the precision that the surgeon can achieve with the use of the robotic tool. That feature, coupled with the continual advances in surgical techniques, has made robotic procecures one of the fastest growing areas of orthopaedic surgery, particularly in revision cases.

The reputation of The Steadman Clinic and its history of innovation must also be recognized as a spur to the quick growth in the numbers of Dr. Gallizzi’s surgeries since his arrival in Vail.

“The long-standing innovative history that Dr. Steadman initiated at his Clinic really drove it to be one of the country’s leaders in orthopaedic surgery,” Dr. Gallizzi said. “All of us at The Steadman Clinic continue that belief and follow those practices that Dr. Steadman established in making the patient’s recovery and return to activity as efficient and pain-free as possible.

“Our robotics program works with that same philosophy,” Dr. Gallizzi continued. “Any major institution throughout the United States has a robotics program. And we have the same service line that any major academic hospital has because of that. 

What lies ahead for Dr. Gallizzi and the rapidly growing field of robotics surgery?

“It’s the case application of robotic surgery that enables the procedures to continue to grow,” said Dr. Gallizzi. “I’ve been using the robot for some posterior cervical work, which was typically done in a more open fashion. 

“We’re also able to start applying it to the younger athletes with pars repair, which is a surgical method to treat a pars defect, a condition that affects the lumbar/lower spine. Treatment is required to stabilize portions of the lower and upper vertebrae that have become separated from repeated stress and strain. We encounter this a lot with freestyle skiers and ski jumpers.

“One of the newer uses of the robotic tool is in the revision space,” added Dr. Gallizzi. “For some cases where we need to remove hardware, I’m actually able to put the scope through the robot as a targeting tool. There I do some of the work with the scope, in combination with the robot to be able to remove deep hardware that’s hard to access.”

Dr. Gallizzi was invited to the Society for Minimally Invasive Spine Surgery to give a lecture about the current state of robotic surgery at their conference in Melbourne, Australia in May. “I will be headed there to talk about the current challenges we face and where we’re going with robotic spine surgery. Here in Colorado, it went from me being the first user of this system back in 2019 to where there are now about 17 robots of this type placed in our state alone. That’s just in a four-year timespan. That’s how much things have changed. You can imagine that probably 15 years from now, if you’re not using robotic technology in some way, shape or form it may be a struggle, because patients will demand precise, reproducible surgery.”

Source: The Steadman Clinic

Harmonic Bionics Completes First Installation of Curexo’s Morning Walk

Harmonic Bionics has completed the first installation of Curexo, Inc.’s Morning Walk S200 at an inpatient rehabilitation facility in the US.

The Morning Walk S200 is an FDA-registered robotic gait rehabilitation system with a virtual reality component that uses a saddle for weight support and individual foot plates to facilitate more natural walking patterns. Last year, the device was installed at the first outpatient facility in the country. St. David’s Rehabilitation Hospital, which is located at St. David’s Medical Center in Austin, TX, is the first inpatient rehabilitation facility in the US to offer gait training with Morning Walk for patients. 

St. David’s Medical Center was recently named as the top performing Large Community Hospital in the U.S. on the annual Fortune/Merative 100 Top Hospitals® list. The hospital’s 64-bed rehabilitation facility provides comprehensive inpatient and outpatient care for patients with neurological conditions, including stroke and orthopedic illnesses or injuries.

“This is a major milestone for the Morning Walk device as we continue to validate the technology in different settings allowing more patients to experience Morning Walk in America,” said Harmonic Bionics CEO Christopher Prentice. “We are excited to see the device at such a renowned institution right here in Austin and look forward to working with the St. David’s team.”

Source: Harmonic Bionics

Medacta Announces First Surgeries in Japan with NextAR Augmented Reality Surgical Platform

Medacta announces the first NextARTM surgeries have been successfully performed in Japan with its innovative NextAR, Augmented Reality Surgical Platform. NextAR is the first surgical platform to offer personalized augmented reality solutions for both joint replacement and spine procedures leveraging patient-specific, unique real-time data to efficiently complement operative workflow.

Since the recent approval from Japanese Ministry of Health, Labour and Welfare (MHLW), NextAR Platform further enlarges its worldwide outreach, engaging with new surgeons with the aim of achieving better outcomes for patients.

  • NextAR Knee: “NextAR for TKA with GMK Sphere is one of the innovative enabling technologies in Computer Assisted Orthopedic Surgery which could deliver new surgical experience to Japanese surgeons in terms of augmented reality using smart glasses and CT-based ligament balance assessment and biomechanical simulation. Our group believes that it has the huge potential to improve patient outcomes. We are excited to provide new value for our patients,” Dr. Atsushi Sato, Ph.D.
     
  • NextAR Shoulder: “Glenoid implantation is the crucial point of reverse shoulder arthroplasty. In cases with glenoid deformity, we were sometimes in trouble. NextAR Shoulder helps us to easily visualize the bony shape and precisely implant the glenoid component as we planned. I believe this new technology will lead to good clinical results for our patients,” says Dr. Noboru Matsumura.
     
  • NextAR Spine: “NextAR setting up is very simple and navigation of the instruments is easy, with a smart tracking system of the instruments that drastically reduce the line of sight. What I really like about NextAR is the fast and simple procedure to getting started with spine navigation, combined to a very high level of accuracy of the screw placement thanks to the AR glasses” says Dr. Kanji Sasaki. “I think that NextAR combined with M.U.S.T. LT brings an innovative and efficient way to approach spine navigation, the array of navigable instruments is nice and very easy to set up, and the glasses allow me to maintain the focus on the surgical field while navigating the instruments. Accuracy is very impressive. NextAR is a very reliable system,” says Dr. Takeshi Umebayashi.

Through advanced 3D planning tools, a compact and revolutionary single-use tracking system, and augmented reality, NextAR enables data-driven decision-making allowing the surgeon to perform personalized procedures based on each patient’s unique anatomy and biomechanics. These valuable insights are displayed through the NextAR Smart Glasses directly onto the operative field to give the surgeon enhanced visualization and control during the procedure. The increased level of data may provide more precision and could lead to improved patient outcomes.

“We are extremely proud that this unique, lean, and sustainable technology has reached a new relevant market, where it has sparked the interest of many surgeons. NextAR represents a new dimension for enabling technologies, seamlessly integrating into well-established surgical workflows,” says Francesco Siccardi, Chief Executive Officer of Medacta International.

In line with Medacta’s philosophy of healthcare sustainability, the NextAR platform is offered as a hardware system with limited capital investment and single-use instrumentation at a low cost per case and offers the ability to host software for multiple applications. The platform represents an optimal solution worldwide, particularly for US Ambulatory Surgery Centers (ASCs).

The NextAR surgical platform is part of Medacta’s MySolutions Personalized Ecosystem, an advanced network of digital solutions designed to improve patient outcomes and healthcare efficiency. MySolutions embodies Medacta’s holistic approach to personalized medicine, aiming to bring value to every step of the patient journey from preoperative through postoperative care.

NextAR is also supported by the comprehensive, tailored educational offerings provided by the M.O.R.E. Institute. With an international network of expert surgeons, the M.O.R.E. Institute is at the forefront of education on spine procedures and products with personalized high-level educational pathways. With Medacta, the surgeon is never alone.

Source: Medacta

SeaSpine Announces 100th Worldwide Placement of 7D FLASH™ Navigation System

SeaSpine Holdings Corporation has announced the placement of its 100th 7D FLASH™ Navigation System globally. The 7D FLASH™ Navigation System uses visible light to create a three-dimensional image for surgical navigation in just seconds, which is expected to result in shorter and more efficient spinal procedures with less radiation exposure. It is the only marketed image-guidance system that utilizes novel and proprietary camera-based technology, coupled with machine-vision algorithms, to eliminate the long-standing frustrations with legacy surgical navigation platforms.

The 100th system was purchased by Inova Fairfax Hospital in Virginia. “I’m delighted that Inova Fairfax is the hospital system that helped 7D achieve such an important milestone with the placement of its 100th unit, and that Inova is the first in the Washington metropolitan area to be able to offer SeaSpine FLASH Navigation’s cutting-edge technology to my patients undergoing spine surgery,” said orthopedic surgeon Dr. Laurel Blakemore. “Their unique segmental referencing method and FLASH navigation system will protect patients and providers from the cumulative effects of radiation while allowing for more accurate placement of spinal fixation. We can virtually eliminate use of X-ray during the surgery and overall reduce radiation for the patient and save time compared to other navigation systems.”

The speed, accuracy, and efficiency of machine-vision technology is intended to provide significant economic value, lower radiation for staff and patients in open procedures, and harnesses the true potential of image-guided navigation – providing a truly unique offering for both open and minimally invasive spine procedures.

Another recent installation occurred at Parkview Orthopedic Hospital with Dr. Ahmer Ghori. “We are excited to be the first facility in Indiana to offer SeaSpine FLASH Navigation’s cutting-edge technology to patients undergoing spine surgery,” stated Dr. Ghori. “The FLASH Navigation system eliminates intraoperative radiation associated with the ‘spin’ required for traditional navigation technologies, thus leapfrogging operative efficiency while protecting patients and providers from the cumulative effects of radiation. FLASH technology eliminates the challenges of changing the anatomy intra-op with positioning, interbody work, or simply by knocking the reference frame.”

“These milestones represent the continued clinical acceptance that the FLASH™ Navigation system has seen since joining the SeaSpine family in 2021,” said Brian Stuart, Vice President of Sales, Enabling Technologies at SeaSpine. “As we continue to deliver new functionality like the recently launched percutaneous spine module for minimally invasive spine procedures, we expect to see continued growth throughout the US, and around the world with this game changing technology.”

Source: SeaSpine