Medtronic Received CE Mark for Extravascular Defibrillator System, used to treat Abnormal Heart Rhythms

On February 17, 2023, Medtronic plc, the leading global healthcare technology company, received CE mark for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation lead, to treat fast heart rhythms that can lead to sudden cardiac arrest. The Aurora EV-ICD system is indicated for patients who are at risk of life-threatening arrhythmias, who have not had a prior sternotomy, and who do not need chronic bradycardia (abnormally slow heartbeat) pacing.

The lead (thin wire) of the device Aurora EV-ICD system is placed outside the heart and veins so the system provides the life-saving benefits of traditional ICDs while avoiding certain risks. The Aurora EV-ICD system provides defibrillation, anti-tachycardia pacing (ATP), and backup pacing therapies to the patients via a single implanted device that is similar in size, shape, and longevity to traditional ICDs.

In the United States, the Aurora EV-ICD system is still under investigation.

Using a minimally invasive approach, the Aurora EV-ICD is implanted below the left armpit (in the left mid-axillary region) and the Epsila EV lead is placed under the breastbone (sternum). The placement of the lead outside of the heart and veins is intended to reduce the risk of long-term complications associated with transvenous leads, such as vessel occlusion (narrowing, blockage, or compression of a vein) and blood infection risks. 

Results of the global pivotal study: 

  • The device’s effectiveness in delivering defibrillation therapy at implant was 98.7%
  • Greater defibrillation efficacy for EV-ICD was reported than historical transvenous ICD studies
  • The EV ICD study was comparable to ATP efficacy in transvenous defibrillators. In total, 33 shocks were avoided by having ATP programmed “on.”
  • At six months, 92.6% of patients were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death
  • No major intraprocedural complications, nor any unique complications were observed related to the EV-ICD procedure or system

“The growing awareness by patients and physicians about the risks that come with placing leads in the heart or veins is addressed by the Aurora EV-ICD system that provides an extravascular solution while maintaining the traditional ICD benefits of pacing and defibrillation therapy,” said Lucas V.A. Boersma, M.D., Ph.D., a cardiologist at St. Antonius Hospital, Department of Cardiology, Nieuwegein, The Netherlands, and Professor of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, The Netherlands.

Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic, said, “We are proud to be the first company to offer a complete one-system, one-procedure extravascular ICD solution, which maintains the patient benefits of traditional, transvenous ICDs without the risk of leads in the heart and vasculature.” Cheng further added, “This approval is a significant milestone in achieving our goal of delivering a defibrillation solution that treats sudden cardiac arrest while improving the patient experience.”

As per DelveInsight’s Defibrillator Market” report, the global defibrillator market was valued at USD 10.19 billion in 2021, growing at a CAGR of 3.11% during the forecast period from 2022 to 2027 to reach USD 12.24 billion by 2027. The demand for defibrillators is primarily associated with the growing incidence of cardiac disorders, integration of advanced technology, increasing investments by government and private manufacturers, and rising awareness programs regarding cardiovascular disorders and the usage of defibrillators, among others. As per the Delveinsight analysis, in the product type segment of the defibrillator market, single chamber implantable cardioverter defibrillators (ICD) are expected to hold a significant revenue share in the year 2021. Single chamber implantable cardioverter defibrillators (S-ICDs) are the recent development in the field of defibrillators that have many advantages over traditional or transvenous ICDs. They mainly lower the risk of vascular injury or pneumothorax. Also, the absence of leads is the main advantage making it a great alternative for children with congenital heart diseases or patients with no venous access who were unsuitable for transvenous ICD. The device is well tolerated than the traditional ICDs thereby raising the demand for ICDs in the coming years.

Dexcom G6 Continuous Glucose Monitoring System Launched in Singapore

On February 21, 2023, Dexcom, Inc., a global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, launched Dexcom G6 CGM System in Singapore for people with diabetes aged two years and older, including pregnant women, and also appointed the DKSH Singapore Pte Ltd as sales, marketing, and distribution service provider. 

The Dexcom G6 is a small, wearable sensor, and transmitter which continuously measure and send glucose levels wirelessly to a receiver or a compatible smart device, enabling patients to receive real-time glucose data without the need to prick the finger. The G6 system also offers customizable alerts and alarms to help avoid dangerous low and high-blood sugar events. 

The Dexcom G6 app is compatible with both iOS and Android devices and allows patients to share their glucose information with up to ten followers, enabling family, loved ones, and healthcare providers to remotely monitor the patient’s health for extra peace of mind. Also, the patients can see glucose readings on the optional Dexcom G6 touchscreen receiver that can be purchased separately. 

“The launch of Dexcom G6 in Singapore is a significant milestone for our company,” said Scott Moss, VP at Dexcom, Asia-Pacific. Moss added, “This launch marks the first time Dexcom CGM is available to people living with diabetes in Southeast Asia, and with the recent opening of our regional headquarters in Singapore, we look forward to bringing Dexcom CGM to additional markets in the region soon.”

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 demand for blood glucose monitoring systems is predominantly attributed to the increasing prevalence of diabetes among the population across the globe. Further, the growing burden of the geriatric population who are susceptible to develop hyperglycemia coupled with increase in technologically advanced product launches, and government initiatives to raise awareness regarding proper diabetes management, among others are the factors that are likely to spur the global blood glucose monitoring systems market during the forecast period. 

Cognito Therapeutics Enrolled First Patient in the US Pivotal Study HOPE 

On February 21, 2023, Cognito Therapeutics, a clinical-stage neurotechnology company, enrolled the first patient in its US pivotal study (HOPE), designed to demonstrate the safety and efficacy of its proprietary non-invasive stimulation device CogTx-001 in patients with Alzheimer’s disease

The HOPE Study for Alzheimer’s disease evaluates CogTx-001, a novel wearable device that can slow the progression of Alzheimer’s disease, without the safety concerns associated with medications or highly invasive procedures. 

The device CogTx-001 has been tested in multiple clinical studies. Patients who used the CogTx-001 in the OVERTURE study reported a reduction in disease progression of 83% as measured by the Mini-Mental State Exam (MMSE) and 78% as measured by the Alzheimer’s disease Cooperative Study-Activities of Daily Living (ADCS-ADL). Over 6 months, patients who used the Cognito device showed a significant reduction in brain atrophy and preservation of white matter.

The HOPE is a blinded sham-controlled study in which 400 patients with Alzheimer’s disease will use Cognito’s proprietary non-invasive wearable device at home daily for 12 months. The 12-month HOPE study is intended to build on the success of the OVERTURE study by demonstrating both the slowing of disease progression as measured by the ADCS-ADL primary endpoints and a combined statistical test (CST) of the ADCS-ADL and the MMSE, as well as slowing of brain atrophy as measured by MRI. The study will also assess secondary endpoints such as the change from baseline in the Clinical Dementia Rating – Sum of Boxes (CDR-SB).

“Our first patient enrolment in the HOPE pivotal study is a key milestone for Cognito, as we advance our non-invasive, disease-modifying therapeutic platform for the treatment of Alzheimer’s patients,” said Brent Vaughan, CEO of Cognito Therapeutics. Brent Vaughan also commented, “It is a hopeful time for patients and families living with Alzheimer’s with multiple new treatments in late-stage development for this intractable disease. Our HOPE study is designed to potentially offer patients a novel safe approach to treating Alzheimer’s disease by slowing both declines in brain function and brain atrophy – both hallmarks of Alzheimer’s progression. We look forward to bringing a new option for Alzheimer’s patients and families in desperate need of new therapies and believe our novel approach will enable more combinations of therapies to better treat this disease.”

Michelle Papka, Ph.D., Director and Founder of The Cognitive and Research Center of New Jersey, said, “The HOPE study offers a rare opportunity for patients with mild to moderate Alzheimer’s disease to participate in a research study utilizing technology as an intervention.” Michelle added, “Patients and their family members have expressed great interest in enrolling in this study because it is non-invasive and represents a novel and safe approach to potentially slowing the progression of Alzheimer’s disease.”

According to DelveInsight’s “Deep Brain Stimulation Devices Market” report, the global deep brain stimulation devices market was valued at USD 1.31 billion in 2021, growing at a CAGR of 10.40% during the forecast period from 2022 to 2027, to reach USD 2.37 billion by 2027. The demand for deep brain stimulation devices (DBS) is primarily attributed to the growing prevalence of movement disorders such as Parkinson’s disease, the expansion of disease indications for DBS therapy, the rising geriatric population, and increasing research and development activities in product development among others are expected to aid in the growing demand for DBS devices leading to the growth of the DBS devices market during the forecast period. As per the Delveinsight analysis, in the by-product type segment, the dual channel deep brain stimulation systems are estimated to account for a prominent market share in the year 2021. This can be ascribed to the fact that dual channel neurostimulators are equipped with two separate DBS leads which enable the devices to provide bilateral therapy to patients. The placement of dual-channel DBS systems requires fewer incisions and less tunnelling of extensions which prove to be advantageous over single-channel DBS systems.

Stryker’s Q Guidance System for Cranial Applications Received FDA Clearance

On February 17, 2023, Stryker, one of the world’s leading medical technology companies, received 510(k) clearance for Q Guidance System with Cranial Guidance Software from the US Food and Drug Administration. The Q Guidance System is an image-based planning and intraoperative guidance system designed to support cranial surgeries. It was launched in September 2022 for spinal applications and is currently available in the market.

The Q Guidance System with Cranial Guidance Software is indicated for any medical condition where computer-assisted planning and surgery may be appropriate, and it can also be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. It follows navigated instruments and displays their position and orientation in patient images. The Cranial Guidance Software includes automatic, algorithmic processing and comprehensive guidance data to increase surgical confidence and ability.

Stryker’s Q Guidance System powers the Cranial Guidance Software and can be used with a variety of instruments and accessories for navigated cranial procedures. The software, which is new for brain biopsies, includes a dedicated workflow to support the precise alignment of the Precision Targeting System with a pre-operatively planned approach. 

The company is also utilizing plug-in EM tracking technology for the placement of shunt catheters, which can be visualized with an EM Stylet, in both adult and pediatric patients.

“The FDA clearance of Stryker’s Q Guidance System with Cranial Guidance Software is a key milestone, which will help lead the transformation of cranial navigation and surgery,” said Robbie Robinson, president of Stryker’s Spine division. Robinson, added, “Our robust pipeline of iterative launches reinforces our commitment to making industry-leading investments focused on providing advanced navigation products and differentiated technologies that our surgeon customers have come to expect.”

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 2021, growing at a CAGR of 5.81% during the forecast period from 2022 to 2027, to reach USD 7,765.22 million by 2027. 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 products, increasing demand for minimally invasive surgeries, and others will create a necessity for image-guided surgery devices in the market. As per the Delveinsight analysis, North America is expected to dominate the overall image-guided surgery devices market during the forecast period. This can be ascribed to the increasing prevalence of various chronic diseases such as neurology, cardiovascular, cancers, and orthopedic, among others in the region.

Rhaeos Raised $10.5M in Series A Funding to Launch Novel Hydrocephalus Shunt Monitor and Accelerate Pipeline Product Development 

On February 16, 2023, Rhaeos, Inc., a clinical-stage medical device company focused on addressing an unmet need in the care of people with hydrocephalus, announced the successful closing of $10.5 million in Series A funding led by the Steele Foundation for Hope, bringing Rhaeos’ total funding to date to more than $18 million. Other round participants include follow-on investors, Creative Ventures and Lateral Capital. 

The funds will be used to support the in-hospital launch of the FlowSense shunt monitor, a wireless, non-invasive thermal sensor that rapidly monitors shunt function in hydrocephalus patients. The funding will also help to speed up the development of the company’s pipeline products, such as an at-home version of the FlowSense shunt monitor, and pave the way for better-serving people with hydrocephalus in vulnerable communities around the world.

The FlowSense system employs a small, bandage-sized patch that is applied to the skin above the implanted shunt tubing. In a matter of minutes, critical data on shunt functionality is wirelessly transmitted to a mobile app, assisting clinical decision-making and optimizing treatment plans.

Rhaeos received FDA Breakthrough Device Designation for the FlowSense shunt monitor in 2020, allowing the company to work with the FDA to streamline the market clearance process. 

The FlowSense shunt monitor is currently being evaluated in an FDA pivotal study at multiple sites across the United States. The FlowSense shunt monitor is expected to be commercially available to physicians and their patients in 2023.

“Our mission is to fund technology and innovation focused on improving the quality of life. Rhaeos’ technology addresses a critical unmet need for those suffering from hydrocephalus, how to monitor shunt function and improve clinical decision making,” said Joe Exner, Chief Executive Officer of the Steele Foundation for Hope. Joe Exner said, “Our investment will enable the exceptional team at Rhaeos to expand access to its innovative thermal sensors across the globe, improving the quality of care and outcomes for hydrocephalus patients.”

David D. Limbrick, Jr., MD., Ph.D., T.S. Park Chair and Chief of Pediatric Neurosurgery, Washington University School of Medicine, and Neurosurgeon-in-Chief, St. Louis Children’s Hospital, stated, “Current diagnostic imaging tests used to assess shunt function are limited and can take up to 48 hours, leaving patients with hydrocephalus vulnerable to the damaging effects of excess cerebrospinal fluid on the brain.” David D. added, “The FlowSense technology allows me to assess my patient’s shunt function at their bedside in minutes, reducing diagnostic uncertainty and expediting appropriate treatment for people living with this highly complex, chronic condition.”

Anna Lisa Somera, MS, MBA, MPH, Chief Executive Officer, Rhaeos, said, “At Rhaeos, we are passionate about improving the care of people living from hydrocephalus.” Lisa also commented, “We are grateful for this round of financing that will advance the availability of our innovative shunt monitor to significantly improve the management of failed shunts and accelerate the development of our platform technology to improve the care of other chronic conditions.”

According to DelveInsight’s “Hydrocephalus Shunts Market” report, the global hydrocephalus shunts market to observe significant market growth, primarily owing to the mounting figures of various brain and neurological disorders. Further, an increase in the geriatric population base, increasing adoption of advanced programmable valves, increasing product launches and approvals, surging investments by key players, and others will ultimately affect the demand for hydrocephalus shunts certainly in the coming years. In addition, increasing awareness regarding hydrocephalus, and increasing numbers of brain injuries, traumatic injuries, and hemorrhagic stroke will positively affect the market for hydrocephalus shunts in the upcoming years.  

Synchrony Medical Enrolled First Patients in the US Study of its LibAirty™ Airway Clearance System

On February 16, 2023, Synchrony Medical, a MEDX Xelerator portfolio company, enrolled the first patient in its single-center, randomized-controlled, crossover clinical study of its LibAirty™ Airway Clearance System at the Medical University of South Carolina. MEDX Xelerator is a leading medical device and digital health-focused incubator operating under the auspices of the Israel Innovation Authority.

The study is led by principal investigator Dr. Patrick A. Flume, Director of the Adult Cystic Fibrosis and Bronchiectasis Center. The study aims to determine the safety and efficacy of the LibAirty™ airway clearance system in patients with Bronchiectasis.

The LibAirty™ System is intended to allow patients who require airway clearance to clear their lungs using a simple adaptive wearable device. The system is built on proven airway physiology principles to improve secretion movement and thoroughly clear even the smallest, most affected, and difficult-to-clear airways. 

Dr. Flume said, “Patients with bronchiectasis worldwide are at risk for worsening symptoms, or exacerbations, many of which may result in hospitalization, due to poor airway clearance and lung infections. Synchrony Medical’s LibAirty™ could provide an effective way to reduce symptoms and prevent exacerbations. For this reason, we are conducting a clinical trial in which we will be enrolling patients with bronchiectasis for whom we have prescribed daily airway clearance, to examine the system in comparison to the current standard of care. If all works as anticipated, LibAirty™ could become an important tool in addressing the significant clinical need for airway clearance.”

“We believe that LibAirty™ brings new concepts for effective and personalized airway clearance treatment to this market, and we hope the US study will replicate the promising clinical results demonstrated so far and become the new standard of care for airway clearance,” said Synchrony Medical CEO Anat Shani. According to DelveInsight’s “Therapeutic Respiratory Devices Market” report, the global therapeutic respiratory devices market is expected to grow at a CAGR of 8.61% during the forecast period from 2022 to 2027. The therapeutic respiratory devices market is anticipated to witness prosperity owing to the rising prevalence of respiratory disorders such as COPD, asthma, and others.  Furthermore, the increasing geriatric population and increasing use of tobacco and cigarettes over the last decade will fuel the market growth of the therapeutic respiratory devices’ industry. Advancement in products due to research and developmental activities in this sector is another factor that will result in appreciable revenue growth of the therapeutic respiratory devices market during the forecast period (2022-2027).