Olympus Launched Next Generation Electrosurgical Generator

On June 06, 2023, Olympus Corporation, a global medical technology company, launched its newest electrosurgical generator, ESG-410 for use in the treatment of bladder cancer and enlarged prostate.

By offering a variety of resection loops, band electrodes, vaporization buttons, and needles, the ESG-410 Electrosurgical Generator promotes alternatives and efficiencies in the treatment of benign prostatic hyperplasia (BPH), or an enlarged prostate, and non-muscle-invasive bladder cancer (NMIBC).

The ESG-410 is designed with larger capacitors that allow for better plasma stability during ignition. The generator also needs less energy for an ignition and offers enhanced procedural efficiency in BPH resections due to faster tissue removal because of the reliable ignition of larger resection loops. 

The ESG-410 has faster ignition and improved plasma stability without tissue contact with large, medium, and band loops and oval buttons. Also, the device offers a larger 8.4″ LCD touch screen than the ESG-400 with wireless foot pedals. In different variations, wired options are available.

ESG-410, the Electrosurgical Generator is designed for cutting and coagulating tissue in open, laparoscopic, and endoscopic surgery. The operator or patient may suffer from thermal or other harm if this electrosurgical generator is used incorrectly or with incompatible equipment, which can result in excessive or inaccurate high-frequency (HF).

As per DelveInsight’s “Electrosurgical Devices Market” report, the global electrosurgical devices market was valued at USD 8,520.99 million in 2022, growing at a CAGR of 6.64% during the forecast period from 2023 to 2028 to reach USD 12,401.80 million by 2028. The rise in the demand for electrosurgical devices is predominantly attributed due to the growing prevalence of chronic disorders such as cardiovascular disorders, neurological disorders, gynaecological disorders, and others, the rising number of surgical procedures, the escalating burden of geriatric patients, and technological advancements in product development and design improvement.

Biocomposites Added Proprietary NanoBone® Technology to its Portfolio through the Acquisition of Artoss GmbH 

On June 06, 2023, Biocomposites, a medical devices company that engineers, manufactures, and markets world-leading products for regenerating bone and managing infection in the bone and soft tissue, announced the acquisition of Artoss GmbH (Artoss), a specialist manufacturer of innovative bone graft substitutes for use in orthopedics, spine, foot and ankle, and dentistry.

Using its patented NanoBone® technology, which combines nanocrystalline hydroxyapatite and silica gel to deliver excellent bone development with simple handling, Artoss offers a variety of bone graft alternative solutions. The unique structure of NanoBone® activates the body’s natural bone-forming mechanisms and promotes very quick bone healing. 

The company offers a wide variety of indication-specific product variants that are all ready-to-use, directly from their applicators, in addition to Artoss’ lead product NanoBone® SBX Putty.

Artoss, based in Rostock, Germany, will continue to create cutting-edge products, but will now be able to serve a greater number of surgeons and patients through access to Biocomposites’ established global distribution network.

Michael Harris, Chief Executive Officer of Biocomposites, commented, “We are delighted to have completed this acquisition of Artoss. Adding the NanoBone® range of products to our portfolio provides us with a new differentiated offering to help surgeons treat their patients and a platform from which to develop new ready-to-use products. Following on from our acquisitions of Subiton and Synimed last year, we have established ourselves as the go-to provider for surgeons requiring bone regeneration and/or managing infection in the bone and soft tissue.”

According to DelveInsight’s Bone Grafts and Substitutes Market” report, the global bone grafts and substitutes market was valued at USD 3.20 billion in 2022, growing at a CAGR of 6.09% during the forecast period from 2023 to 2028 to reach USD 4.56 billion by 2028. The demand for bone grafts and substitutes is primarily witnessing growth due to the growing prevalence of degenerative bone disorders, the rising number of trauma cases, the increasing geriatric population, and the rising requirement for bone grafts and substitutes in dentistry.

Artelon, Inc. Received FDA Clearance for FlexBand®, FlexPatch®, and FlexBand Plus® used for Ligament Reinforcement 

On June 06, 2023, Artelon Inc., a global healthcare leader which is an expert in synthetic materials for real-world success in orthopedic soft tissue reconstruction, received the US FDA 510(k) clearance for FlexBand®, FlexPatch®, and FlexBand Plus® for ligament repair surgery in addition to tendon repairs. 

This new clearance expands the indications for these products including reinforcement of medial, lateral, and ulnar collateral ligaments, spring ligaments, deltoid ligaments, and extra-articular ligaments in the ankle, knee, and other joints around the body.

FlexBand®, FlexPatch®, and FlexBand® Plus are designed to be used during surgical procedures to strengthen soft tissue where it is weak.

Additionally, FlexBand®, FlexPatch®, and FlexBand® Plus are designed to reinforce soft tissues that are stitched together or fixed with other devices during surgery to repair tendons and ligaments. These soft tissues include the rotator cuff, patellar, Achilles, biceps, and quadriceps tendons, as well as the medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, and ulnar collateral ligament. 

Dynamic Matrix technology from Artelon is a proprietary polymeric bio-textile for musculoskeletal soft tissue reinforcement that is used in Flexband products.  The mechanical and biological characteristics of recovering tendon and ligament tissue are mimicked by Dynamic Matrix. It has been demonstrated in clinical investigations to encourage the formation of regenerative tissue before dissolving over several years, immediately restore the mechanics of motion, and protect the surgical repair during early healing.

“This new regulatory clearance establishes a unique and specific framework of U.S. marketing claims for reinforcement of ligaments,” said CEO Aaron Smith.  Aaron Smith further added, “Recent innovation in our space has been mostly focused on fixation of ligaments to the bone, but little has been done to address the failure of the ligament tissues themselves, which are often diseased and may lead to poor surgical outcomes.  We are currently a leader in the large and growing U.S. ankle instability market.  This new set of claims permits us to take on a multitude of unmet clinical challenges in the ankle and other joints and dramatically expand our addressable market.”

According to DelveInsight’s Bone Growth Stimulators Market” report, the global bone growth stimulators market was valued at USD 1.26 billion in 2022, growing at a CAGR of 5.34% during the forecast period from 2023 to 2028 to reach USD 1.73 billion by 2028. The bone growth stimulators market is witnessing positive market growth owing to factors such as the prevalence of degenerative bone-related disorders, increasing cases of accident and traumatic cases such as road crashes, sports injuries, and others, the growing burden of the geriatric population who are susceptible to developing various bone degenerative disorders, and the accumulative focus on developing technologically advanced devices concerning bone growth stimulators among others.

Masimo Announced FDA 510(k) Clearance of Radius VSM™

On June 05, 2023, Masimo, a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions, announced that Radius VSM™, a patient-worn, continuous multi-parameter vital signs monitor, received FDA 510(k) clearance. 

Radius VSM enables medical professionals to track a wide range of physiological parameters, including non-invasive blood pressure, temperature, respiration rate, and electrocardiography (ECG) using Masimo SET® pulse oximetry. Radius VSM enables ambulation and movement while guaranteeing that patients are continuously monitored by combining the convenience and independence of a wearable device with the dependability and accuracy of bigger bedside monitors.

Radius VSM allows providers to equip any hospital bed with comprehensive monitoring, with the ability to quickly add or remove measurement technologies to match each monitoring scenario and offer more personalized care – without additional bedside equipment, network infrastructure, or any tethered connections.

Radius VSM can be used as a standalone device due to its built-in multi-touch LED display, built-in rechargeable battery, high-quality waveform, and parameter trend data, as well as visual and audible alarms. By automating the transfer of patient data to remote monitoring systems, the device can streamline clinical workflows. This enables Radius VSM to be utilized as a part of a patient monitoring system and ensures that clinicians across the hospital have access to the most recent physiological data. 

Using a multi-functional pod and a variety of modules and non-invasive sensors designed to prioritize comfort and ergonomics, Radius VSM offers the following measurement technologies:

  • Clinically proven Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, including oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), pleth variability index (PVi®), and plethysmographic respiration rate (RRp®)
  • Multiple respiration rate measurements, including measurement from the pleth, from the sound of breathing, and impedance
  • Measure-on-inflation non-invasive blood pressure (NIBP), featuring single-patient-use cuffs and automatic intervals (which reduces the need for periodic manual clinician measurement)
  • Continuous skin temperature measurements with notifications when clinician-specified temperature thresholds are breached
  • Patient orientation, position, and activity monitoring alert clinicians to unsupervised patient movement and possible patient falls, as well as preventable pressure injuries
  • ECG: continuous 6-lead monitoring (I, II, III, aVR, aVL, and aVF) with heart rate, respiration rate, and lethal arrhythmia detection, using single patient use easy-to-apply pre-connected 3-electrode lead wire
  • Rainbow Acoustic Monitoring®, which uses an adhesive sensor to detect the acoustic signals produced by airflow in the upper airway and convert these patterns into respiration rate, also visualized as a waveform

Joe Kiani, Founder, and CEO of Masimo said, “Radius VSM’s unique scalability, versatility, advanced connectivity, and a broad range of accurate and automated continuous measurements – all in a wearable device that can be quickly and easily deployed anywhere in the hospital – make it a game-changing tool for clinicians everywhere. Doctors, nurses, and patients in Europe are already experiencing the advantages of Radius VSM and we are excited to share them with U.S. hospitals now too.”

Peter Pronovost, MD, Ph.D., FCCM, Chief Quality and Clinical Transformation Officer at University Hospitals, Ohio, and Clinical Professor of Anesthesiology and Perioperative Medicine at Case Western Reserve School of Medicine, commented, “Radius VSM represents another radical transformation of care by Masimo, allowing clinicians to monitor based on patient acuity, not their location. With this new technology, not only can every bed have pulse oximetry monitoring, but if patient acuity increases, we can also easily scale up monitoring, even including ECG, without having to add new hardware or hardwire anything. With the staff shortages in hospitals and the high volume of patients, clinicians need the flexibility to put patients in any bed and ensure that that bed can monitor each patient appropriately. With Radius VSM, we will have enormous flexibility to manage patient risk across a hospital or, in our case, an entire health system: we can tailor what gets monitored to meet each patient’s need, for truly personalized monitoring. And from a safety perspective, by allowing us to monitor patients based on their acuity and needs, linked to clinical protocols, we can significantly drive down the risk of possible harm in the hospital.”

Thomas Callahan, MD, Principal Investigator and Director of the Inpatient Hospital Service for Cardiac Electrophysiology and Pacing, at Cleveland Clinic, mentioned, “We are excited to have gained early experience with this next-generation inpatient monitoring system at our center as part of the investigational study. What helps differentiate this technology from existing systems is high fidelity continuous ECG monitoring in a compact modular configuration and integration with high precision optical, electrical, and acoustic sensors for blood pressure, respiratory rate, pulse oximetry, and motion.”

According to DelveInsight’s “Patient Monitoring Devices Market” report, the global patient monitoring devices market was valued at USD 35.21 billion in 2022, growing at a CAGR of 8.20% during the forecast period from 2023 to 2028 to reach USD 56.46 billion by 2028. The escalating demand for patient monitoring devices is primarily attributed to the increase in the prevalence of various chronic and lifestyle-associated disorders. Moreover, the sudden outbreak of the COVID-19 pandemic has also contributed to the patient monitoring devices market. Additionally, the growing preferences for remote patient monitoring systems among the patient and healthcare providers, the increase in technological advancement in the product arena, and the rise in the approval of various patient monitoring devices in the current year, among others are also some of the factors responsible for potentially increasing the global patient monitoring devices market during the forecast period (2023-2028).

Gore Announced the First US Enrollment for the GORE® VIAFORT Vascular Stent iliofemoral Study

On June 06, 2023, W. L. Gore & Associates (Gore), a global materials science company dedicated to transforming industries and improving lives, announced that the first US patient has been enrolled in a prospective, non-randomized, multicentered, single-arm study with five-year follow-up (NCT05489588) to evaluate the investigational GORE® VIAFORT Vascular Stent for the treatment of symptomatic iliofemoral venous obstruction. 

The GORE VIAFORT Vascular Stent utilizes the Gore expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single wire, sinusoidal-wound nitinol frame.

The GORE VIAFORT Vascular Stent Iliofemoral Study is evaluating the device in a treatment range of 10 to 20 mm diameter for iliofemoral veins. The study is being conducted in the U.S. under an approved investigational device exemption (IDE).

The first U.S. patient was enrolled by David J. Dexter II, M.D. at Sentara Vascular Specialists, Norfolk, Virginia, who said, “With several FDA-approved stents on the market, there was a concern that enrollment in another iliac vein stent trial would be difficult. Designed with the unique qualities for flexibility and radial force, the VIAFORT Device is compelling to use in a clinical trial.”

According to DelveInsight’s “Vascular Stents Market” report, the global vascular stents market was valued at USD 13.31 billion in 2022, growing at a CAGR of 7.90% during the forecast period from 2023 to 2028, to reach USD 21.01 billion by 2028. The increase in demand for vascular stents is predominantly attributed to the growing prevalence of vascular disorders such as atherosclerosis, carotid artery diseases, and peripheral artery diseases, among others. In addition, growing preferences for minimally invasive surgeries among the patient population, growing technological advancement in the product arena, and approval of various vascular stents, among others are some of the factors responsible for driving the global vascular stents market in the forthcoming years.

Synergy Spine Solutions Completed Enrollment in 1-Level IDE Trial 

On June 05, 2023, Synergy Spine Solutions Ltd, an innovative orthopedic medical device developer focused on artificial cervical disc replacement, completed enrollment in it’s first-ever IDE clinical trial.

In a multi-center, prospective, historically controlled pivotal trial comparing the safety and efficacy of the Synergy Disc to anterior cervical discectomy and fusion in patients with one-level symptomatic cervical degenerative disc disease, the 1-Level Synergy Disc IDE clinical trial (NCT 04469231) enrolled 175 patients. A pre-market approval (PMA) application in the United States will be supported by the study, which is being carried out at 20 locations across the country.

Josh Butters, Synergy Spine Solutions CEO, said, “We are thrilled to announce that we have fully enrolled in our 1-Level Synergy Disc trial. This is an incredible achievement for our team and it has been a very rewarding collaboration with some of the best clinical sites and spine surgeons in the US. We are excited to continue following these patients, further building Synergy’s clinical evidence, and advancing our pre-market approval strategy for the Synergy Disc in the U.S.” 

Dr. Todd Lanman, a spinal neurosurgeon with Beverley Hills-based Lanman Spinal Neurosurgery, founder of the national ADR Advanced Disc Replacement Spinal Restoration Center and a Principal Investigator for the trial, commented, “Having been involved in the Synergy Disc 1-Level artificial disc replacement clinical trial, my impressions of how the disc performs is quite interesting. I just enrolled one of the last trial patients in the study and, after having performed thousands of cervical artificial disc replacements, the Synergy Disc has provided unique performance enhancements. Particularly, the Synergy Disc corrects the curve of the spine because the implant has a six-degree lordotic correction which has been quite beneficial for realigning the curve of the neck to its proper position.”

According to DelveInsight’s “Spinal Fusion Devices Market” report, the global spinal fusion devices market was valued at USD 6.49 billion in 2022, growing at a CAGR of 4.55% during the forecast period from 2023 to 2028 to reach USD 8.47 billion by 2028. 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 and the 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.