Neuspera Medical Announces First Successful Implant of the Nuvella™ System in the Second Phase of Its Sans-Uui Ide Clinical Trial

On October 10, 2022, Neuspera Medical, a medical device company involved in the development of implantable devices for patients suffering from chronic illnesses, announced that the first patient had been successfully implanted with the Nuvella™ system in its pivotal clinical trial (SANS-UUI). 

The study aims to evaluate the safety and efficacy of the Nuvella system, that is designed for the treatment of overactive bladder (OAB) with sacral neuromodulation (SNM) in patients showing symptoms of urinary urgency incontinence (UUI). 

Around 145 patients worldwide will participate in the prospective, multi-center, single-arm trial. The results of the SANS-UUI feasibility phase were first presented at the American Urological Association (AUA) annual meeting in September 2021 and again at the Society of Urodynamic, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) winter meeting in 2022. In 34 patients who had the Nuvella system implanted, 90% of the individuals showed 50% improvement in UUI symptoms at 6 and 12 months with two hours of daily stimulation, and 52% were dry throughout the 12-month visit.

The complete procedure was performed by Dr. Jodi Michaels of Minnesota Urology, St. Paul, MN.

“We are pleased to enroll the first patients in our pivotal SANS-UUI trial, an important milestone for the company. Kicking off enrolment builds on the strong momentum from our feasibility experience,” states Steffen Hovard, CEO of Neuspera Medical. He further added, “This technology has the potential to revolutionize the way physicians utilize SNM therapy to treat patients battling chronic conditions while restoring patients’ health and quality of life.” 

As per DelveInsight’s Stress Urinary Incontinence Devices Market” report, the global stress urinary incontinence devices market was valued at USD 757 million in 2021, growing at a CAGR of 6.91% during the forecast period from 2022 to 2027, to reach USD 1130.32 million by 2027. The demand for stress urinary incontinence devices is primarily being boosted by the increasing cases of urinary incontinence among women, the increasing geriatric population across the globe, the rise in the number of risk factors for urinary incontinence, including menopause, pregnancy, and others, and the rising technological advancements are expected to cause an increase in the stress urinary incontinence devices demand thereby contributing in the growth of the stress urinary incontinence devices market during the forecast period from 2022-2027.

Thermo Fisher Scientific Launched CE-IVD Marked TaqPath Enteric Bacterial Select Panel

On October 10, 2022, Thermo Fisher Scientific, a serving science company, announced the launch of CE-IVD marked panel named TaqPath Enteric Bacterial Select Panel that is intended for the detection of common gastrointestinal (GI) bacteria and allows healthcare professionals to recognize the root cause of infection for better treatment predictions. 

Based upon polymerase chain reaction (PCR) technology, a variety of common GI bacteria, including Salmonella spp., Shigella spp./ enteroinvasive E. coli (EIEC), Campylobacter jejuni, Campylobacter coli, and Campylobacter upsaliensis can be analyzed using the new test. In around two hours, it can reliably deliver data with greater than 98 percent sensitivity and specificity. In contrast, it can take up to two weeks for laboratory culturing of materials to get results.

Dr. Manoj Gandhi, senior medical director of Genetic Testing Solutions, Thermo Fisher Scientific, said: “The TaqPath Enteric Bacterial Select Panel’s ability to identify and differentiate between the most common diarrhea-causing pathogens will make testing more accessible and provide laboratorians with more agility when identifying GI bacteria.” He further added, “Detecting these different pathogens in a single test can preserve precious lab resources while still providing clinicians critical information needed to make the right treatment decisions for their patients.”

According to DelveInsight’s “Gastroendoscopes Market” report, the global gastroendoscopes market was valued at USD 3.29 billion in 2021, growing at a CAGR of 6.69% during the forecast period from 2022 to 2027, to reach USD 4.85 billion by 2027. The gastroendoscopes market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of gastrointestinal diseases across the world growing prevalence of stomach and oesophageal cancer coupled with the rising geriatric population. Moreover, the increasing focus of manufacturers to develop technologically advanced gastroendoscopes, are likely to propel the market growth of gastroendoscopes in the upcoming years.

ZEISS Medical Technology Receives 510(k) clearance FDA Clearance for MTLawton

On October 10, 2022, ZEISS Medical Technology received 510(k) FDA Clearance for the new generation of bipolar forceps for Electrosurgery named MTLawton. 

These novel disposable bipolar forceps may lessen tissue adhesion and consequent charring during tissue dissection since they are constructed from a specific copper-based alloy. The forceps’ longer shaft also helps the surgeons to work more effectively during electrosurgical operations by removing obstructions to their field of vision in the operating room.

The production and development of MTLawton is based on close collaboration with Michael T. Lawton, one of the world’s leading neurosurgeons. 

 “The MTLawton Disposable Bipolar Forceps are a real advance in electrosurgery over aluminum forceps. Our copper-base alloy has superior thermal conduction to improve cautery-based hemostasis and reduce tissue adhesion,” commented Michael T. Lawton, MD, President and CEO, Chair, Department of Neurosurgery, Barrow Neurological Institute. He remarked, “I take these MTLawton bipolar into battle with all my difficult arteriovenous malformations, and they give me a noticeable advantage.”

According to DelveInsight’s “Surgical Energy Instruments/Electrosurgical Devices Market” report, the global surgical energy instruments/electrosurgical devices market was valued at USD 8,520.99 million in 2021, growing at a CAGR of 6.64% during the forecast period from 2022 to 2027, to reach USD 12,401.80 million by 2027. The increase in demand for surgical energy instruments/electrosurgical devices is predominantly attributed to the growing number of surgical procedures, innovative product developments, and the rise in the number of chronic diseases such as cancer, cardiovascular, kidney, and neurological diseases, among others. 

Abbott Reports Positive Data from Clinical Trial on FreeStyle Libre 2 system

On October 07, 2022, Abbott, a leading medical devices and healthcare company, announced that it had received positive data from a randomized clinical trial of its FreeStyle Libre 2 glucose monitoring system. 

The study aimed at evaluating the efficacy of the FreeStyle Libre 2 system enrolled 156 people aged 16 years and above having Type 1 diabetes with sub-optimal glycaemic control and was published in the New England Journal of Medicine. 

A significant reduction in glycated hemoglobin (HbA1c) was observed with FreeStyle Libre 2 glucose monitoring system as compared to self-monitoring of blood glucose (SMBG). In the trial, the HbA1c reductions were sustained by the patients for the duration of the 24-week study. Additionally, the participant-reported improved quality of life outcomes, including overall satisfaction and reduced burden related to glucose monitoring. After the duration of six months, the average HbA1c levels system were 0.8% less in participants who used the FreeStyle Libre 2. 

“This randomized study clearly illustrates the importance of continuous glucose monitoring for adults with Type 1 diabetes,” said Dr. Mahmood Kazemi, Abbott Diabetes Care Business chief medical officer.  

According to DelveInsight’s Blood Glucose Monitoring Systems Market” report, the global blood glucose monitoring systems market was valued at USD 13.06 billion in 2021, growing at a CAGR of 7.72% during the forecast period from 2022 to 2027 to reach USD 20.40 billion by 2027. The increasing demand for blood glucose monitoring systems is primarily associated with the growing prevalence of diabetes worldwide, the increasing number of risk factors for diabetes, the integration of advanced technology, increasing investments by government and private manufacturers, and the rising awareness programs regarding diabetes care, and increasing geriatric population, among others. As per DelveInsight’s Analysis, in the blood glucose monitoring systems market by product type, continuous glucose monitoring systems are expected to hold the largest share in the market owing to various advantages associated with it, such as providing real-time and dynamic information on trends of glucose levels, and increasing product launches among others. 

Life Spine Receives FDA 510(k) Clearance for the GHOST® 3D-Printed Titanium Spacer System

On October 05, 2022, Life Spine, a medical device company and manufacturer of market products for the surgical treatment of spinal disorders, received the 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the GHOST 3D-Printed Titanium Spacer Systems

Expanding on Life Spine’s interbody portfolio, which already comprises PEEK, and titanium, the new GHOST 3D-Printed Titanium Spacer System includes solutions for ALIF, PLIF/TLIF, and other lateral procedures. 

Porous surfaces are incorporated into GHOST spacers to encourage bone on-growth while preserving a solid exterior lattice shape. To meet different patient anatomy and pathologies, GHOST comes in a variety of footprints and lordotic offers. AVATAR® Percutaneous Screw System, NAUTILUS® Spinal Fixation System, CENTERLINE® Midline Screw System, and ARx® Spinal Fixation System are just a few of Life Spine’s many posterior fixation options that are added to the system’s simplified instrumentation. 

“We are excited about the expansion of our interbody portfolio to include 3D-printed implants. Our robust offering is one of the broadest in the industry and includes solutions for nearly every procedure and surgeon preference. With the PEEK, Titanium, and Expandable interbody product lines, the addition of 3D-Printed Titanium interbodies allows Life Spine to offer physicians alternative solutions to customize their patient’s treatment,” commented Mariusz Knap, Sr. Vice President of Marketing. 

According to DelveInsight’s “Spinal Fusion Devices Market” report, the global spinal fusion devices market was valued at USD 6.49 billion in 2021, growing at a CAGR of 4.55% during the forecast period from 2022 to 2027, to reach USD 8.47 billion by 2027. The demand for spinal fusion devices is motivated by a rise in the prevalence of spinal disorders such as degenerative disc disorders, spinal stenosis, and others, coupled with the rising geriatric population. Furthermore, technological advancements in product portfolios will drive market growth. 

BIOCORP and Merck KGaA, Announced New Partnership for Smart Drug Delivery 

On October 10, 2022, BIOCORP, a French-based medical devices company, and Merck KGaA, a leading science and technology company based in Germany, entered into a partnership with the intention of developing and supplying a specific version of the Mallya device as an accessory for one of Merck KGaA’s drug delivery devices. 

Mallya is a clip-on Bluetooth-enabled device for pen injectors that records each injection’s dose and time and transmits that data in real time to a companion program. Mallya is the first medical device in its category to gain the CE mark, and commercial insulin pen injectors are already on the market and being sold in Europe and other regions. 

With Sanofi, Novo Nordisk, and Merck KGaA, Darmstadt, Germany, major agreements have already been made by BIOCORP to develop specialized versions of the technology in the fields of insulin and human growth hormone (HGH).

A new version of Mallya will be created by the healthcare firms BIOCORP and Merck KGaA, Darmstadt, Germany, to assist patients in monitoring their injections during treatment. The apparatus will automatically record the doses injected. 

“We are delighted with this new partnership with Merck KGaA, Darmstadt, Germany, extending our collaboration to additional therapeutic areas. We had already announced that there is a great opportunity for our connected device Mallya in various therapeutic areas. As in diabetes, Mallya aims to reduce patients’ stress and improve compliance with their treatments to optimize and secure the results,” commented Éric Dessertenne, CEO of BIOCORP. 

According to DelveInsight’s “Drug Delivery Devices Market” report, Insights, Competitive Landscape and, Market Forecast – 2027”, the global drug delivery devices market is estimated to grow at a CAGR of 7.90% during the forecast period from 2022 to 2027. Factors such as the increasing incidence of chronic diseases such as diabetes, cancer, and others, rising growth of biologic, increasing technological advancements, and others are expected to bolster the demand for these devices during the forecast period. As per DelveInsight’s study, among all the regions, North America is expected to hold the highest market share. This is primarily attributed to the rising prevalence of chronic diseases in the region and the increasing product launches for the drug delivery devices market.