Bioventus Receives 501(k) Clearance for StimRouter Pain Management Device

On March 1, 2022, the US Food and Drug Administration (FDA) gave Bioventus’ StimRouter Neuromodulation System 510(k) approval. The next-generation pain treatment device is intended to treat chronic pain caused by peripheral nerves, excluding craniofacial pain. StimRouter is a minimally invasive device that includes an implanted thin lead with a conductive electrode, the StimRouter Plus Mobile Application, and an external electric field conductor (E-EFC).

Bioventus chief commercial officer John Nosenzo commented, “The impact of chronic, debilitating pain is more than just managing the impacted anatomy, it is also about helping return the individual back to a life pre-pain. The emotional and psychological damage from living with pain is horrific and we are pleased to support all the physicians who are committed to improving patient lives, in particular with alternatives to opioids when possible. The next generation StimRouter will support patients and physicians to meet their pain treatment goals as the previous generation of peripheral nerve stimulation has done for many years.”

It transmits electrical impulses from the E-EFC through the skin and routes them to the targeted nerve through the implanted lead. The latest version of the StimRouter technology provides similar scientifically proven, long-term pain relief while also vastly improving patient control and user comfort.

According to DelveInsight’s “Neuromodulation Devices Marketreport, the global Neuromodulation Devices market was valued at USD 5.25 billion in 2020, growing at a CAGR of 8.95% during the forecast period from 2021 to 2026, to reach USD 9.23 billion. The demand for neuromodulation devices is primarily motivated by the increasing prevalence of neurological disorders coupled with the rising aging population, expansion of the devices to other chronic indications and target application, technological advancement in the product portfolio, the rising government initiative to raise awareness among patient regarding neurological disorders, among others.

Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence

On March 1, 2022, Valencia Technologies Corporation, a privately held company, announced the US Food and Drug Administration (FDA) gave its eCoin® leadless tibial neurostimulator premarket approval (PMA) for the treatment of urinary urge incontinence (UUI), which affected over 60% of patients with Overactive Bladder (OAB). The effectiveness and favorable safety profile revealed in the eCoin® pivotal study aided the FDA to approve.

eCoin® is a nickel-sized neurostimulator that is implanted subcutaneously in the lower leg using a local anesthetic during a minimally invasive outpatient procedure. eCoin® is the first FDA-approved implantable tibial nerve stimulator. The eCoin® equipment has the main battery and, once set, gives intermittent stimulation to the tibial nerve to help with UUI symptoms.

Jeff Greiner, Founder of Valencia, said, “This is a landmark approval for physicians and UUI patients as eCoin® is now the first and only implantable tibial nerve stimulator approved by the FDA. eCoin® will facilitate a paradigm shift for UUI treatments by offering physicians an efficient option for implantation with high patient satisfaction. The simplicity and effectiveness of eCoin® will enable more patients to achieve the help they desperately need.”

The eCoin® implantable device is leadless, which means there are no delicate wires that must be properly tunneled to reach the desired nerve for therapy. Instead, the eCoin® device is implanted just above the ankle over the tibial nerve, and its forgiving, dome-shaped stimulation field stimulates the nerve regularly to relax the bladder and alleviate bladder leakage.

Dr. Rebecca McCrery, an Investigator in the eCoin® pivotal trial, said, “Beyond delivering impressive results achieved without the need for prior screening, the eCoin® procedure is easily understood by patients, reproducible amongst physicians, and accomplished in a safe and effective manner. Under 5% of OAB patients select burdensome third-line interventions due to invasiveness or potential side effects of available therapies and limitations in access, resulting in a staggering unmet clinical need. The effortless relief provided by the automatic nature of eCoin® neuromodulation therapy will potentially better treat the vast population – often desperate for relief – who are not well managed by the current options available to them.”

The pivotal study, which tracked 133 women and men in the United States who were implanted with eCoin®, was used to support the PMA application for eCoin®. In the per-protocol group, 75% of patients experienced a 50% reduction in UUI occurrences. Before implantation, there was no trial or screening. One year after the treatment, 81% of patients said they felt “better” to “very much better.” Implanted patients had a positive experience, with 97% claiming the surgery was appropriately described to them and 89% reporting they would suggest eCoin® treatment to friends or family.  The company planned to commercialize eCoin® in March 2022, with medical training starting in April 2022.

According to DelveInsight’s “Urinary Incontinence Devices Marketreport, the global Urinary Incontinence Devices market was valued at USD 2.8 billion in 2020, growing at a CAGR of 6.32% during the forecast period from 2021 to 2026, to reach USD 4.03 billion by 2026. The Urinary Incontinence Devices market is expected to witness growth due to the rising prevalence of urinary incontinence cases, development of innovative devices, aging population prone to urological conditions like urinary tract infections, weakening of pelvic floor, and conditions including pregnancy, diabetes, menopause, and Parkinson’s disease.

SurGenTec Launches ION Screw, Smallest Posterior Spinal Fixation Implant, to Market After Receiving FDA Clearance

On March 2, 2022, SurGenTec®, a privately held spine and orthopedic technology firm located in Boca Raton, FL, announced its innovative stand-alone spine fixation implant, the IONTM Screw, has been cleared by the FDA. This one-of-a-kind device may be used to treat a range of spinal diseases from C2 to S1. The ION implant, which is smaller than a dime and can be implanted through a little incision with minimal tissue damage, is the smallest posterior fixation device certified for spine surgery. The NanotexTM surface technology of ION screws has been built with bone interdigitation in mind.

Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec, commented, “The ION screw technology truly changes the game for spine surgery. Patients are looking for options outside traditional bulky metallic devices such as pedicle screws and interspinous plates. This minimally invasive option provides excellent fixation with zero profile. It’s a non-intimidating solution for patients that need to undergo a spine surgery procedure. We are thrilled to announce the addition of ION to our portfolio. Our team has put years into pre-clinical research and development to create this truly novel spinal fixation option. Our team managed to create a ‘micro’ implant with a unique surface technology that provides fixation without the need for cumbersome implants.” 

Facet fusions, adjunct to decompressive operations, the treatment of neighboring level illness, or offering further stability with interbody fusions are just a few of the open or true minimally invasive surgery (MIS) applications where ION can be used. While delivering the ION implants to the surgical region, the ION facet screw system devices were developed to reduce tissue stress and incision size.

Andrew Shoup, Chief Operating Officer of SurGenTec, stated, “The ION system is a great fit for the ambulatory surgery center environment by providing a cost-effective solution for physicians looking to minimize trauma while still providing a high level of spinal care to patients. Patients are demanding access to a more efficient operating environment with less risk of illness and disease transmission.” 

The ION has a zero profile above the bone, unlike conventional spinal fixation solutions, which may reduce soft tissue contact and discomfort. Before and after insertion, the implants may be packed with bone graft to aid fusion allowing bone to bridge over the implant and prevent implant migration.

According to DelveInsight’sSpinal Fusion Devices Marketreport, the global Spinal Fusion Devices market was valued at USD 6.21 billion in 2020, growing at a CAGR of 4.57% during the forecast period from 2021 to 2026 to reach USD 8.08 billion by 2026. The rise in demand for Spinal Fusion Devices is primarily attributed to the rising prevalence of spinal disorders such as degenerative disc disorders, spondylolisthesis, disc herniation, spinal stenosis among the growing old-age population worldwide; increase in demand for minimally invasive surgeries. In addition, technological advancement in the product line and new product launches, among others, are also expected to drive the global spinal fusion market.

Exactech Announces Launch of Humeral Reconstruction Prosthesis in Europe

On March 7, 2022, Exactech, a developer and manufacturer of unique joint replacement implants, instruments, and smart technologies, announced its Equinoxe® Humeral Reconstruction Prosthesis approval for clinical use in Europe.

The Humeral Reconstruction Prosthesis is intended for intraoperative flexibility and patient-specific sizing. It is the first modular device offered in the United States for substantial proximal humeral bone loss and reconstruction after tumor resections. The prosthesis provides several possibilities for achieving stability irrespective of the extent of the proximal humeral excision in both simple and difficult cases. It’s employed in arthroplasty surgeries, including primary and revision, as well as anatomic oncology procedures. The humeral reconstruction prosthesis was first launched in the United States in 2015 and has since been used to treat over 1,500 patients. It is now accessible in the following countries: Italy, France, Spain, Germany, and Great Britain.

Pietro Ruggieri, MD, Ph.D. (Department of Orthopedics and Orthopedic Oncology, University of Padova, Italy), a design surgeon, commented, “The Equinoxe Humeral Reconstruction Prosthesis is designed to treat patients with a wide range of proximal humeral bone loss. This modular prosthesis is capable of reconstructing a patient’s humerus with as little as 50mm of bone loss, while also being able to address the most challenging cases, including patients who have a resection below the deltoid insertion, through the use of additional modular middle segments. I am thrilled that this remarkable device is now available for the treatment of patients in Europe.”

The Humeral Reconstruction Prosthesis’ modularity is a crucial component, with a platform stem and numerous modular segments allowing reconstruction between 50mm – 212.5mm and 60mm – 222.5mm, as well as several soft tissue fixation methods. Due to its unique plasma/hydroxyapatite (HA) coated collars meant for fixation and best fit, the device is designed to provide biomechanical benefits, including rotational stability.

Chris Roche, Sr. Vice President, Extremities, stated, “At Exactech we challenge our development teams to create products that solve unmet clinical needs, and our Humeral Reconstruction Prosthesis is an innovative solution that was designed to address the most difficult humeral challenges shoulder surgeons face. The Humeral Reconstruction Prosthesis was the first reverse TSA device cleared for use in the U.S. for significant resection of the proximal humerus.”

He further added, “It incorporates many unique design features intended to mitigate complications associated with these challenging cases, including collars available in 17 different sizes to achieve rotational stability and fixation for the full range of bone sizes. It also provides numerous proximal body options to achieve joint stability while also lateralizing the deltoid. Our surgeon and engineering teams are proud to deliver this unique and innovative shoulder solution to the European market.”

According to DelveInsight’s “Orthopedic Prosthesis Devices Market”, the global Orthopedic Prosthesis Devices Market was valued at USD 2.11 billion in 2020, growing at a CAGR of 5.88% during the forecast period from 2021 to 2026 to reach USD 2.96 billion by 2026. Orthopedic Prosthesis Devices Market is segmented into By Product Type (Upper Extremity Orthopedic Prosthesis Devices [Shoulder, Elbow, Hand & Wrist, And Fingers], Lower Extremity Orthopedic Prosthesis Devices [Foot & Ankle, Knee, Hip, And  Others]), By Technology (Active [Body-Powered And Electric-Powered] And Passive), By Customization (Prefabricated And Customized), By Age Group (Adult And Pediatric), By End User (Hospitals, Ambulatory Surgical Centers, And Others), and is expected to grow at a steady CAGR forecast till 2026 owing to the increasing cases of limb amputation due to diabetes and trauma injuries.

PathMaker Neuro systems Initiate U.S. Multi-Center Trial Evaluating MyoRegulator® for the Non-Invasive Treatment of Post-Stroke Spasticity

On March 7, 2022, PathMaker Neurosystems Inc., a near-commercial neuromodulation company developing ground-breaking non-invasive systems for the treatment of serious neurological disorders, has announced the start of a multi-center clinical trial in the United States to evaluate MyoRegulator® for the non-invasive treatment of post-stroke upper-limb spasticity. The trial is being conducted with the Spaulding Rehabilitation Hospital in Charlestown, MA, and is funded by a $4.9 million NINDS Cooperative Research to Enable and Advance Translational Enterprises for Devices (CREATE Devices) grant from the National Institute of Neurological Disorders and Stroke (NINDS).

PathMaker’s innovative DoubleStim® technology offers simultaneous stimulation at spinal and peripheral locations, making MyoRegulator® a first-in-class, non-invasive neuromodulation device. It’s the first and only neuromodulation device that works without medicines or surgery to treat muscular spasticity. It has been utilized in two completed clinical studies in the United States and Europe and has been certified as a “breakthrough” medical device by the US FDA.

This pivotal study will be a multi-center, randomized, double-blind, sham-controlled trial that will compare the effectiveness and safety of MyoRegulator® therapy for post-stroke lower-limb spasticity in active vs sham-treated participants, with a total of 76 subjects enrollment.

J. Leon Morales-Quezada, M.D., Ph.D., Director of the Integrative Rehabilitation Lab and Research Associate Director, Spaulding Neuromodulation Center at Spaulding Rehabilitation Hospital, and Study Site Principal Investigator for this study said, “There is a pressing need for novel therapeutic options that do not involve drugs or surgery for the treatment of spasticity. The MyoRegulator® device represents potential new hope for millions of patients living with this disorder around the world. We are thrilled to be involved in this trial with PathMaker and explore bringing this technology closer to clinical practice.”

According to DelveInsight’s “Neuromodulation Devices Marketreport, the global Neuromodulation Devices market was valued at USD 5.25 billion in 2020, growing at a CAGR of 8.95% during the forecast period from 2021 to 2026, to reach USD 9.23 billion. The demand for neuromodulation devices is primarily motivated by the increasing prevalence of neurological disorders coupled with the rising aging population, expansion of the devices to other chronic indications and target application, technological advancement in the product portfolio, an increasing government initiative to raise awareness among patient regarding neurological disorders, among others.

Late-Breaking Study Results Reinforce Positive Real-World Outcomes with the WATCHMAN FLX™ LAAC Device

On February 28, 2022, the WATCHMAN FLXTM Left Atrial Appendage Closure (LAAC) Device had positive outcomes in a recent analysis conducted by Boston Scientific Corporation. The SURPASS analysis, which was presented at a late-breaking trial session at the Cardiovascular Research Technologies (CRT) 2022 meeting, included data from over 16,000 patients with non-valvular atrial fibrillation who were part of the NCDR’s Left Atrial Appendage Occlusion (LAAO) Registry.

The positive outcomes showed a low rate of major adverse events of 0.37% at seven days after a WATCHMAN FLX implant or at the time of hospital discharge, whichever occurred later. A composite of all-cause mortality, ischemic stroke, systemic embolism, or device/procedure-related events requiring open-heart surgery or substantial endovascular intervention was used to define this crucial safety endpoint. A 0.51% rate of pericardial effusion needing surgical or percutaneous intervention was found at the 45-day follow-up following a WATCHMAN FLX implant, with just 0.03% of patients requiring cardiac surgery.

Dr. Samir Kapadia, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute, Cleveland Clinic, said, “This analysis includes the largest number of real-world WATCHMAN FLX patients to date and provides evidence that this stroke reduction therapy is associated with a low incidence of adverse events and peri-device leak through 45 days. SURPASS represents the experience of more than 2,000 physicians using this therapy in routine clinical practice.” 

The WATCHMAN FLX device was implanted successfully in 97.6% of patients in the study, and data showed minimal rates of ischemic stroke (0.28%) and device embolization (0.03%) in patients after 45 days. The SURPASS research is continuing and will continue to collect results for at least two years post-implant on all patients in the NCDR-LAAO Registry treated with WATCHMAN FLX between August 2020 and August 2022. The major effectiveness objective of occurrence of ischemic stroke or systemic embolism will be examined after 24 months.

Dr. Ian Meredith, global chief medical officer, Boston Scientific, said, “The strong safety and efficacy profile of the WATCHMAN FLX device demonstrated in the SURPASS analysis reinforces many of the safety and effectiveness results seen in the pivotal PINNACLE FLX trial while representing a high-risk, real-world patient population and a wide variety of patient anatomies. We look forward to further analyses from this large, representative study of patients with NVAF treated by physicians with a broad range of implanting experience.” 

The WATCHMAN technology has been implanted in over 200,000 people worldwide, and clinical research on the use of the WATCHMAN FLX device in patients with NVAF is still underway through two large prospective, randomized controlled trials: the OPTION and CHAMPION-AF clinical trials.According to DelveInsight’s “‘Left Atrial Appendage Closure Devices Marketreport, the growing cases of atrial fibrillation is the major factor expected to boost the demand for left atrial appendage closure devices market growth. As per CDC 2021, atrial fibrillation was mentioned on 183,321 death certificates and was the underlying cause of death in 26,535 of those deaths in 2019.