Medtronic Secures FDA Approval for First-Ever Adaptive Deep Brain Stimulation System for Parkinson’s; FDA Grants Breakthrough Device Designation to Averto Medical’s ColoSeal™ System; Biomerica’s inFoods® IBS clinical trial findings were published in Gastroenterology; Lungpacer Medical’s STIMULUS Trial Highlights Improved Hemodynamics With Diaphragm Neurostimulation; Alcon Introduces Voyager DSLT; Stryker Finalizes Acquisition of Inari Medical

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Medtronic Secures FDA Approval for First-Ever Adaptive Deep Brain Stimulation System for Parkinson’s; FDA Grants Breakthrough Device Designation to Averto Medical’s ColoSeal™ System; Biomerica’s inFoods® IBS clinical trial findings were published in Gastroenterology; Lungpacer Medical’s STIMULUS Trial Highlights Improved Hemodynamics With Diaphragm Neurostimulation; Alcon Introduces Voyager DSLT; Stryker Finalizes Acquisition of Inari Medical

Feb 27, 2025

Medtronic Earned U.S. FDA Approval for the World’s First Adaptive Deep Brain Stimulation System for People With Parkinson’s 

On February 24, 2025, Medtronic plc, a global leader in healthcare technology, announced that it had received U.S. Food and Drug Administration (FDA) approval for BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI).

Although there is no cure for debilitating neurological conditions like Parkinson’s, deep brain stimulation (DBS) has been transforming the lives of those affected for more than 30 years. Similar to a cardiac pacemaker but designed for the brain, DBS involves a surgically implanted neurostimulator that transmits electrical signals to specific regions of the brain impacted by neurological disorders through a minimally invasive procedure.

Medtronic has now enhanced its Percept™ DBS neurostimulators with exclusive BrainSense™ Adaptive technology, introducing aDBS for individuals living with Parkinson’s. This features personalized therapy based on a patient’s brain activity in real-time—both in clinical settings and in daily life. It provided enhanced symptom control by automatically adjusting stimulation, reducing the need for patients to make manual adjustments.

“Medtronic is the only company in the world to offer an adaptive DBS system that dynamically adjusts therapy in real-time,” said Brett Wall, executive vice president and president of the Medtronic Neuroscience Portfolio. “This new era in Parkinson’s care represents more than a decade of intentional innovation—ushering in personalized neuromodulation at the scale that responds to a patient’s changing needs, equipping clinicians with unparalleled insights, and setting a new standard for DBS therapy”

As per DelveInsight’s “Deep Brain Stimulation Devices Market Report”, the deep brain stimulation devices (DBS) market was valued at USD 1.31 billion in 2023, growing at a CAGR of 10.40% during the forecast period from 2024 to 2030 to reach USD 2.37 billion by 2030. The demand for deep brain stimulation (DBS) devices is experiencing growth due to the increasing prevalence of neurological disorders, such as Parkinson’s disease and epilepsy. The rising geriatric population, which is more susceptible to these disorders, is a major factor driving this trend. Additionally, the growing focus on research and development (R&D) and technological advancements in product innovation are contributing significantly to the positive growth of the deep brain stimulation devices market during the forecast period from 2024 to 2030.

Averto Medical Announced FDA Breakthrough Device Designation for ColoSeal™ Intraluminal Colonic Diversion System 

On February 25, 2025, Averto Medical, a clinical-stage medical device company specializing in minimally invasive gastrointestinal care, announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device Designation for its ColoSeal™ Intraluminal Colonic Diversion (ICD) System. This designation highlighted the potential of ColoSeal™ to significantly improve outcomes for patients undergoing colorectal surgery by eliminating the need for a temporary ostomy.

The FDA’s Breakthrough Device Program was established to expedite the development and review of medical devices that provide substantial advantages over existing alternatives in treating or diagnosing life-threatening or irreversibly debilitating diseases. With this designation, Averto Medical gained prioritized FDA interactions and a streamlined review process, facilitating timely access to this innovative solution for patients and healthcare providers.

“Receiving the Breakthrough Device Designation from the FDA is a significant milestone,” said Grace Carlson, Vice-President of Clinical and Regulatory Affairs at Averto Medical. “This recognition highlights the transformative potential of ColoSeal™ in colorectal surgery. We are committed to advancing this technology to improve patient outcomes, quality of life, and healthcare costs.”

As per DelveInsight’s “Colonoscopes Market Market Report”, the colonoscopes market is growing at a CAGR of 4.78% during the forecast period from 2024 to 2030. The increase in demand for colonoscopes is primarily attributed to the increasing prevalence of intestinal or colorectal cancer, increasing awareness and demand for minimally invasive surgeries, continuous technological advancements of the devices, increased awareness of early diagnosis and treatment of cancer across the world among others are anticipated to bolster the market, thereby contributing to the growth of the colonoscopes market during the forecast period from 2024 to 2030.

Biomerica’s inFoods® IBS clinical trial results were published and featured in Gastroenterology, the leading GI medical journal 

On February 19, 2025, Biomerica, Inc., a global leader in advanced medical diagnostic solutions, announced that patients with Irritable Bowel Syndrome (IBS) experienced significant relief from abdominal pain when following a dietary therapy created and guided by the in Foods® IBS blood test. Findings from a clinical trial, published in Gastroenterology, demonstrated that participants who adhered to a personalized diet therapy based on the test results showed greater symptom improvement compared to those following a sham (placebo) elimination diet.

The in Foods® IBS test was specifically designed for IBS patients. It identified individual foods that triggered an elevated (above-normal) Immunoglobulin G (IgG) antibody response—a marker of inflammation associated with IBS symptoms. Each food in the in Foods IBS panel was set with a 95% confidence interval cutoff to ensure accurate results. No other IBS product incorporated this technology.

Irritable bowel syndrome (IBS) affected an estimated 10% to 15% of adults in the United States and was known to significantly reduce quality of life and work productivity. The condition presented a range of symptoms, including abdominal pain and cramps, which could be exacerbated by consuming certain foods.

“We had patients all the time who said, ‘I know food is a problem for me. Is there any way to figure out which foods I’m sensitive to?’” said Prashant Singh, MBBS, Michigan Medicine gastroenterologist and lead author of the study.

Study Design and Key Findings

The randomized, multicenter, double-blind, placebo-controlled trial enrolled 238 IBS patients across eight leading academic centers in the U.S. Each participant was tested for IgG antibody responses to 18 common IBS trigger foods using the in Foods IBS® product. Patients were then randomly assigned to one of two groups:

  • The treatment group eliminated actual foods identified by the in Foods test as triggering an abnormally high IgG antibody immune response in that patient.
  • The control group (placebo) followed a sham diet that removed foods for which the patient tested negative with the in Foods IBS test and consumed a similar amount (e.g., if a patient tested positive for walnuts, they were instructed to eliminate almonds from their diet).

The study found that 59.6% of patients in the treatment group, who eliminated their identified trigger foods, met the FDA-standard target for abdominal pain reduction, compared to 42.2% in the control group. Notably, the benefits were most pronounced in patients with IBS-C (constipation-predominant IBS) and IBS-M (mixed constipation and diarrhea). Among IBS-C patients, 67.1% in the treatment group met the FDA target for pain reduction, versus 35.8% in the control group. Similarly, 66% of IBS-M patients in the treatment group experienced a reduction in pain that met the FDA target, compared to 29.5% in the control group.

“Patients had done all sorts of IgG antibody testing before, and it wasn’t very reliable. This latest test is supported by science. I can refer patients to this IBS-specific antibody testing, after explaining the science and the limitations of the study,” said Dr. Prashant Singh, MBBS.

According to DelveInsight’s “Inflammatory Bowel Disease (IBD) Diagnostic Market Report”, the global Inflammatory Bowel Disease (IBD) Diagnostic market is estimated to grow at a CAGR of 5.13% during the forecast period from 2024 to 2030. The demand for Inflammatory Bowel Disease (IBD) Diagnostic is primarily being boosted owing to the rising prevalence of inflammatory bowel disease globally, the increasing number of risk factors for inflammatory bowel diseases, and rapid research & recent developments activities in gastrointestinal science studies, among others during the forecast period from 2024 to 2030.

Lungpacer Medical Announced Positive Results From the STIMULUS Trial, Demonstrating That Diaphragm Neurostimulation Improved Hemodynamic Performance During Mechanical Ventilation 

On February 20, 2025, Lungpacer Medical, a neurostimulation company dedicated to developing interventional therapies to help patients wean off mechanical ventilation (MV) while preserving or improving diaphragm, lung, heart, and brain health, announced the results of the STIMULUS trial, a Phase 1 clinical study conducted in collaboration with Toronto General Hospital. The trial investigated the use of diaphragm neurostimulation to enhance hemodynamic performance in patients receiving invasive mechanical ventilation. The findings, which demonstrated improvements in hemodynamic performance, were presented at the 2025 Transcatheter Heart Therapies (THT) conference, an esteemed international gathering of experts in cardiovascular research and interventions.

Lungpacer Medical’s investigational AeroNova System consisted of a cardiovascular catheter embedded with stimulating electrodes and a software-controlled system designed to contract the diaphragm via transvenous phrenic nerve neurostimulation. The system aimed to facilitate ventilation using lower positive pressures from the ventilator, thereby reducing ventilator-induced injury to the lungs, diaphragm, heart, and brain in mechanically ventilated patients.

The STIMULUS trial (NCT05465083) represented a significant milestone in the advancement of medical technologies aimed at optimizing patient care in intensive care units (ICUs). This single-center study evaluated the safety and efficacy of diaphragm neurostimulation, delivered via the investigational AeroNova System, in patients with acute hypoxemic respiratory failure or post-thoracic surgery respiratory failure. A key outcome of the study assessed how diaphragm activation, when synchronized with mechanical ventilation, improved cardiovascular function and mitigated the adverse hemodynamic effects commonly associated with invasive mechanical ventilation.

Study Overview and Results

The study enrolled 19 patients, of whom 16 underwent a stimulation titration procedure. The majority of these patients, 12 out of 16 (75%), had pre-existing cardiac dysfunction and exhibited a high incidence of right ventricular dysfunction and/or pulmonary hypertension. Using the AeroPace Catheter, transvenous bilateral neurostimulation was delivered safely, with stimulation levels titrated to achieve diaphragm activation, resulting in increasing levels of expiratory occlusion pressure. The study assessed a range of cardiac outcomes at baseline and after treatment.

Key Findings:

  • Cardiac Function Improvement: Increasing levels of diaphragm neurostimulation significantly increased cardiac index (p=0.003) and stroke volume index (p=0.016), indicating improved heart performance and enhanced blood flow.
  • Enhanced Mean Arterial Pressure: Mean arterial pressure rose significantly (p=0.002), supporting overall hemodynamic stability.
  • Decreased Pulmonary Artery Pressure: Pulmonary artery pressure decreased (p<0.001), likely due to reduced pulmonary vascular resistance. This reduction was particularly important for patients with cardiovascular compromise and pulmonary hypertension, where the heart struggles to pump blood through the lungs.

The study results indicated that diaphragm neurostimulation warranted further exploration as a novel therapy to counteract the harmful cardiovascular effects associated with positive pressure ventilation by improving cardiac function and pulmonary hemodynamics. The findings suggested a dose-response relationship, where increasing stimulation correlated with further improvements in cardiac and pulmonary parameters, providing a strong foundation for future investigation.

“In critically ill patients receiving mechanical ventilation, cardiac and circulatory performance can be significantly impaired by the effects of positive pressure ventilation,” said Dr. Ewan Goligher, an Associate Professor in the Interdepartmental Division of Critical Care Medicine at the University of Toronto and a Clinician Scientist at the University Health Network. “The STIMULUS trial results indicate that diaphragm neurostimulation shows promise in reversing the adverse effects of positive pressure ventilation, which may lead to improved outcomes for these very ill patients.”

According to DelveInsight’s “Neurostimulation Devices Market Market Report”, the neurostimulation devices market was valued at USD 5.82 billion in 2023, growing at a CAGR of 11.77% during the forecast period from 2024 to 2030, to reach USD 11.34 billion by 2030. The market for neurostimulator devices is experiencing significant growth, driven by several key factors. The rising incidence of chronic diseases, such as migraine, headaches, and epilepsy, has created a greater demand for effective treatment options, leading to increased use of neurostimulators. Additionally, the prevalence of lifestyle-related diseases like depression and chronic pain has surged, further boosting the need for these devices as they offer promising solutions for managing these conditions. Technological advancements in neurostimulator devices have also played a crucial role, with regulatory bodies across the globe approving a growing number of innovative and advanced products. This regulatory support has facilitated the widespread adoption of neurostimulators, enhancing their market growth. Collectively, the increasing incidence of chronic and lifestyle diseases, along with the adoption of advanced, approved neurostimulator devices, is driving the expansion of this market during the forecast period from 2024 to 2030.

Alcon Announced U.S. Launch of Voyager DSLT, First-of-its-Kind Treatment for Glaucoma and Ocular Hypertension

On February 19, 2025, Alcon, the global leader in eye care dedicated to helping people see brilliantly, announced the full U.S. commercial availability of Voyager™ DSLT, the first and only Direct Selective Laser Trabeculoplasty (DSLT) device. Voyager DSLT was uniquely positioned to accelerate the adoption of laser as a first-line therapy, expanding treatment access for more patients. Designed to enhance both the patient and physician experience, Voyager DSLT was fully automated—efficiently delivering 120 laser pulses without requiring a gonio lens, unlike manual SLT. Attendees of the 2025 American Glaucoma Society (AGS) meeting in Washington, D.C., from February 26 through March 2, had the opportunity to experience Voyager DSLT firsthand at the Alcon booth (#29-32) and during the launch event.

“I have been using Voyager DSLT since October of 2024, and it has made an incredible impact on the use of SLT for my practice,” said Inder Paul Singh, MD, President of The Eye Centers of Racine and Kenosha. “My patients have been delighted by the efficiency, comfort level of the treatment, and overall experience. Voyager DSLT has been embraced by my staff and is easy to implement, allowing me to treat more of my patients with a recognized first-line standard in glaucoma treatment”

According to DelveInsight’s “Ophthalmic Lasers Market Report”, the ophthalmic lasers market was valued at USD 1.43 billion in 2023 and is likely to register a CAGR of 4.44% during the forecast period from 2024 to 2030 to reach USD 1.94 billion by 2030. The growing demand for ophthalmic lasers stems from several factors. Firstly, there’s a rise in eye diseases like glaucoma and cataracts, which necessitate laser treatments. Additionally, advancements in technology and the introduction of new products are driving market growth by improving treatment options and outcomes in ophthalmology during the forecast period from 2024 to 2030.

Stryker Completed the Acquisition of Inari Medical, Inc., Providing Entry Into the High-Growth Peripheral Vascular Segment 

On February 19, 2025, Stryker, a global leader in medical technologies, announced that it completed the acquisition of Inari Medical, Inc., a company that provides innovative solutions for venous thromboembolism (VTE) clot removal without the use of thrombolytic drugs. The addition of Inari had strengthened Stryker’s position in the fast-growing VTE segment within the peripheral vascular market.

Inari’s product portfolio was highly complementary to Stryker’s Neurovascular business and included two novel mechanical thrombectomy solutions—the FlowTriever System for the treatment of pulmonary embolism and the ClotTriever System for thrombectomy in the peripheral vessels—as well as emerging therapies.

“The acquisition of Inari Medical marks a significant milestone in expanding our interventional endovascular portfolio,” said Kevin Lobo, Chair and Chief Executive Officer, Stryker. “We look forward to welcoming the talented Inari team to Stryker and working together to improve outcomes for patients worldwide.”

According to DelveInsight’s “Peripheral Vascular Clot Management Interventions Market Report”, the peripheral vascular clot management Interventions market is estimated to grow at a CAGR of 7.43% during the forecast period from 2024 to 2030. The demand for Peripheral Vascular Clot Management Interventions is primarily being boosted owing to the increasing prevalence of cardiovascular diseases such as strokes, pulmonary embolism, and others, rise in the number of lifestyle disorders such as hypertension and obesity among others, thereby contributing to the overall growth of the Peripheral Vascular Clot Management Interventions market during the forecast period from 2024 to 2030.

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