DuPont Launched Higher-Adhesion and Low-Cyclics Silicone Soft Skin Adhesive

On October 17, 2023, DuPont, a globally recognized leader in technology for a broad range of innovations in medical devices, biopharmaceutical processing, and pharmaceutical solutions launched Liveo™ MG 7-9960 Soft Skin Adhesive. 

Liveo™ MG 7-9960 Soft Skin Adhesive, the higher-adhesion, low-cyclics silicone soft skin adhesive (SSA) is designed for advanced wound care dressings and adhering medical devices to the skin for long wear time and gentle removal.

The Liveo™ MG 7-9960 Soft Skin Adhesive has the highest peel adhesion in the Liveo™ SSA family. It offers better conformability, atraumatic removal, high repositionability, improved wear performance, and design flexibility. In addition, low-cyclics Liveo™ MG 7-9960 SSA is non-sensitizing, non-irritating, and non-cytotoxic, making it ideally suited to protect the highly sensitive and fragile skin of populations including children, the elderly, and patients with skin conditions or open wounds.

“As difficult-to-heal wounds are increasingly prevailing and wound-healing rates need to improve, we are looking at expanding our portfolio of medical-grade adhesive solutions and partnering with medical device OEMs and converters to support them in developing their new dressing or wearables designs,” said DuPont™ Liveo™ Healthcare Solutions Global Strategic Marketing Leader Jennifer Gemo, one of the webinar presenters.

“Because each device design and process is specific to each customer, it is critical to not only supply high-quality, high-performance materials but also to support customers in optimizing their development,” said DuPont™ Liveo™ Healthcare Solutions EMEA Technical Service and Development Professional and Medical Device Expert Audrey Wipret. 

According to DelveInsight’s “Surgical Sealant and Adhesives Market” report, the global surgical sealant and adhesives market was valued at USD 2.18 billion in 2022, growing at a CAGR of 7.58% during the forecast period from 2023 to 2028 to reach USD 3.39 billion by 2028. The surgical sealant and adhesives market is slated to witness prosperity owing to the growing prevalence of chronic health problems such as cardiovascular problems, kidney problems, neurological issues, and others. The rise in road accidents requiring urgent surgeries is another factor in the growth of the surgical sealant and adhesives market. The continuous rise in cosmetic surgeries and growing focus on improving the safety, affordability, and usability of surgical sealants and adhesives are further expected to result in appreciable revenue growth in the surgical sealant and adhesives market during the forecast period (2023-2028). 

Mindray Collaborated with Edwards Lifesciences for the Integration of the FloTrac™ Sensor for Multiparameter Bedside Monitoring

On October 12, 2023, Mindray, a global leader and developer of healthcare solutions and technologies in ultrasound, patient monitoring, and anaesthesia announced a cooperative agreement with Edwards Lifesciences, a global leader in medical innovations for structural heart disease and critical care monitoring. 

Under the agreement, the companies will provide a solution that makes Mindray’s BeneVision N-Series the first patient monitoring system to integrate with Edwards FloTrac™ sensor for hemodynamic monitoring in the North American market. 

The BeneVision N-Series Patient Monitors combine the advanced hemodynamic parameters of the FloTrac™ sensor with other vital sign parameters, which can give critical care providers greater knowledge about the patient’s physiological status. The FloTrac™ sensor technology expands the N-Series capability to monitor patients’ hemodynamic condition. It enables clinicians to act more proactively to prevent patient deterioration and apply individualized fluid management for patients in surgical and acute care settings. 

The collaboration is a testament to the companies’ commitment to improving clinical decision-making, and productivity, and ultimately advancing patient care.

“At Mindray, we are continuously searching for new ways to improve patient outcomes by providing the most innovative technology on the market,” said Wayne Quinn, President, of Mindray North America. Wayne Quinn added, “Collaborating with industry-leading companies such as Edwards Lifesciences enables us to deliver a comprehensive monitoring solution that gives clinicians access to trusted, evidence-based technology to meet the acute care needs of their hospital and enhance patient safety.”

As per 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 patients 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). 

GE HealthCare Received FDA Clearance for Allia IGS Pulse – an Image-Guided System Designed for Cardiac Imaging Excellence 

On October 16, 2023, GE HealthCare, a global medical technology, pharmaceutical diagnostics, and digital solutions innovator, received US FDA 510(k) clearance for Allia IGS Pulse – the latest addition to the company’s image-guided system (IGS) offerings. Allia IGS Pulse features a new imaging chain engineered to provide exceptional imaging at the right dose for visible impact in complex cardiology interventions regardless of patient size.

The system features the first monopolar X-ray tube used to capture images for interventional procedures. The tube is powerful, yet quieter than normal conversation to optimize the operating environment during a procedure. The small footprint of the new tube also helps clinicians reach steep angulation for a better understanding of coronary artery anatomy, even with the 30cm detector configurations. 

The latest version of MyIQ technology incorporated into the system allows clinicians to select their favorite image look from four different image styles with just one click for a tailored experience at no additional dose. 

With Allia IGS Pulse, physicians can get exceptional image quality for large and bariatric patients with a BMI of greater than 30. The system’s reduced pulse width and unmatched X-ray peak power help to decrease motion blur for better visualization of moving elements such as vessels and devices. 

Allia IGS Pulse takes AutoRight, the company’s intelligent image chain leveraging AI, a step further with AutoRight PLUS – the next generation of the automation platform. With AutoRight PLUS, the system optimizes seven parameters in real-time, including Focal Spot Shape. To further optimize dose along the image chain, a unique suite of tools is also available to help support dose efficiency, dose reduction, and dose awareness.

“At Clinique Pasteur in Toulouse, we perform thousands of interventional cardiology procedures each year,” said Dr. Nicolas Dumonteil, Interventional Cardiologist, Clinique Pasteur, and Toulouse. Dr. Nicolas also added, “As an operator of the Allia IGS Pulse system, I felt a significant and real improvement in the imaging quality, as well as a significant reduction of this noise in my daily procedures which gave me great confidence and comfort in the operating room. The system is also quite adaptable and versatile to all of my daily situations and procedures – from percutaneous coronary interventions (PCIs) to other complex and structural ones.”

“I saw a significant improvement in the image quality, especially with obese patients and complex angioplasties – where a good visibility of my guidewire, balloons, and stents are particularly important,” commented Dr Raphaël Philippart, Interventional Cardiologist, Clinique Pasteur, Toulouse.

“Interventional cardiology procedures require exceptional image quality,” said Arnaud Marie – General Manager of Interventional for GE HealthCare. Arnuad Marie further added, “I’m excited by the addition of Allia IGS Pulse to our interventional offerings because it addresses the very things clinicians continue to tell us present challenges in their day-to-day practice. By developing new features to further evolve our core platform, we’re helping to reduce complexity and improve the operating environment so that clinicians can have a personalized workspace that better enables them to keep their focus where it belongs – on their patients.”  

According to DelveInsight’s “Image-Guided Surgery Devices Market” report, the global image-guided surgery devices market was valued at USD 5,540.87 million in 2022, growing at a CAGR of 5.81% during the forecast period from 2023 to 2028 to reach USD 7,765.22 million by 2028. The image-guided surgery devices market is observing remarkable market growth due to factors such as the escalating burden of the geriatric population prone to chronic diseases and the rising prevalence of chronic diseases such as cardiovascular, cancers, neurological, and others across the globe. Further, a gradual increase in approval of image-guided surgery devices, rapid technological advancement in the products, increasing demand for minimally invasive surgeries, and others will create a necessity for image-guided surgery devices in the market. Therefore, the market for image-guided surgery devices is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

FDA Cleared the EndoCore EBUS-TBNA Biopsy Device by Praxis Medical

On October 17, 2023, Praxis Medical, a medical device company headquartered in Tampa, FL, received the US Food and Drug Administration (FDA) 510(k) clearance for the EndoCore EBUS-TBNA fine needle biopsy device. 

Lung cancer is diagnosed and staged by endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA). During the procedure, a bronchoscope is used to implant a long, flexible tiny needle for biopsy and pathological investigation. If growth is cancerous, it can be determined by examining the collected cells under a microscope for tumor-specific mutations that will help with treatment.

A cutting-edge tool called the EndoCore was created to improve the results of this treatment. A motor inside the apparatus rotates the biopsy needle to make it easier to collect cells. The needle can tear off substantial amounts of tissue using this special rotational motion, which can aid doctors in developing thorough diagnoses.

“We are excited by the implications of how this device could progress the standard of care. Improving EBUS-TBNA sensitivity, diagnostic yield, and ancillary testing capabilities would allow for an expedited workup of all types of adenopathy while maintaining procedural efficiency and low complication rates,” said Dr. Joseph Romero, a Pulmonologist at Morton Plant Hospital in Clearwater, FL. Dr. Joseph further added, “We expect the EndoCore device will collect larger samples of tissue with higher cellularity which could translate to higher success rates for ancillary testing. This will be particularly important for rarer tumors, metastatic disease, lymphoma, and benign diseases such as sarcoidosis where traditional EBUS-TBNA has a lower yield.”

According to DelveInsight’s “Biopsy Devices Market” report, the global biopsy devices market is anticipated to grow at a CAGR of 5.1% during the forecast period from 2023 to 2028. The biopsy devices market is witnessing positive growth owing to various factors such as the increasing prevalence of breast cancer, rising incidence of lung cancer, rise in the geriatric population, and rising technological advancements concerning product offerings. Therefore, the market for biopsy devices is estimated to grow during the forecast period from 2023 to 2028.

Visioneering Technologies, Inc. (VTI) Announced Positive Interim 1-Year Data from the PROTECT Clinical Trial

On October 12, 2023, Visioneering Technologies, Inc., producer of the NaturalVue® Multifocal 1 Day Contact Lenses, presented interim data from the PROTECT Clinical Trial. 

Interim 1-year data from the PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) clinical trial, conducted across four countries, demonstrated the safety and effectiveness of NaturalVue Multifocal (NVMF) contact lenses in controlling myopia progression in pediatric patients.

Key findings of the study included:

  • The preliminary 1-year findings affirmed NVMF’s effectiveness in slowing myopia progression. 
  • Over 12 months, the treatment effect yielded a 69% (0.41Diopter) reduction in refractive error compared to the control group. 
  • For axial length, the treatment effect measured 0.17 mm, a notable 59% reduction. 
  • The data aligns with prior real-world analyses, further validating NVMF’s efficacy.

Dr. Ashley Tuan, VTI’s Chief Medical Officer, said, “The preliminary 1-year data confirms our belief in the safety and effectiveness of NaturalVue Multifocal for pediatric patients. NVMF not only ensures clear vision but also effectively manages myopia. The interim 1-year treatment effects are consistent with those of the only treatment approved by the U.S. Food and Drug Administration for myopia progression control. We eagerly anticipate sharing more insights from the study.”

VTI’s CEO, Dr. Juan Carlos Aragón, added, “VTI’s innovative and easily adaptable lens design plays a pivotal role in tackling pediatric myopia, one of the most pressing concerns in optometry today. We’re thrilled to unveil the 1-year interim results of our PROTECT RCT, demonstrating the effectiveness of NaturalVue Multifocal in managing myopia in children.”

According to DelveInsight’s “Contact Lenses Market” report, the global contact lenses market was valued at USD 9,974.25 million in 2022, growing at a CAGR of 5.14% during the forecast period from 2023 to 2028 to reach USD 13,436.70 million by 2028. The contact lenses market is slated to witness prosperity owing to factors such as the growing prevalence of ophthalmic diseases such as myopia, presbyopia, and astigmatism among others, increasing sedentary lifestyle as well screen time, growing aging population base which is susceptible to the development of presbyopia, and the growing focus on improving the safety and usability of contact lenses for end users are further expected to result in the appreciable revenue growth in the contact lenses market during the forecast period (2023-2028).

SynerFuse Completed Enrollment in Proof-of-Concept Study of the Electric Transforaminal Lumbar Interbody Fusion (e-TLIF™) procedure

On October 17, 2023, SynerFuse, completed the enrollment of participants in its proof-of-concept study to evaluate the safety and tolerability of the Electric Transforaminal Lumbar Interbody Fusion (e-TLIF™) procedure integrating spinal fusion with direct nerve stimulation, which is designed to treat neuropathic chronic lower-back pain (cLBP). The enrollment completion comes after the company completed surgeries on 15 proof-of-concept study patients.

e-TLIF™ procedure is designed to avoid treatment failure, multiple spinal fusions, and risky opioid therapy that typically precedes a neuromodulation implant. SynerFuse intends to stop the cycle of surgeries and medications and aims to provide patient relief faster.

“As we mark the completion of enrollment and the final treatment in our proof-of-concept study, we take another important step towards evaluating our novel SynerFuse™ e-TLIF™ procedure,” said Justin Zenanko, CEO of SynerFuse. 

“Currently, if patients have persistent chronic back and leg pain after a successful fusion, they may eventually become candidates for neuromodulation therapy, but typically only several years after surgery, during which time they may suffer disabling pain and opioid medication use,” said Rohan Lall, M.D., co-investigator with M Health Fairview University of Minnesota Medical Center. Rohan Lall further added, “This is an important goal for the study: addressing the need for non-narcotic pain management therapy earlier on to avert the need for opioids. If the SynerFuse™ e-TLIF™ procedure proves effective at lowering post-operative pain levels, as early indications have suggested, we may have a new treatment strategy that potentially saves the healthcare system billions of dollars and improves pain management outcomes.”

“The 15th patient implant in our proof-of-concept study represents an important milestone for SynerFuse™. We look forward to evaluating the outcome data to inform our pivotal trial,” said Greg Molnar, Ph.D., chief science officer of SynerFuse™.

“The progress we have made demonstrates our commitment to design the SynerFuse™ e-TLIF™ procedure in a manner aimed at avoiding treatment failure, multiple spinal fusions, and risky opioid therapy,” said Zenanko. Zenanko also said, “With this milestone, we advance our mission to improve patient quality of life and address the opioid crisis head-on.”

According to DelveInsight’s “Neuromodulation Devices Market” report, the global neuromodulation devices market was valued at USD 5.71 billion in 2022, growing at a CAGR of 8.95% during the forecast period from 2023 to 2028, to reach USD 9.56 billion by 2028. 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 applications, technological advancement in the product portfolio, rising government initiatives to raise awareness among patient regarding neurological disorders, among others.