Olympus Announced Market Launch of EVIS X1™ Endoscopy System

On October 19, 2023, Olympus Corporation, a global medical technology company announced the market launch of its next-generation EVIS X1™ endoscopy system.

The GIF-1100 gastrointestinal videoscope indicated for use in the upper digestive tract, and the CF-HQ1100DL/I colonovideoscope, indicated for use in the lower digestive tract, were approved earlier this year along with the EVIS X1 endoscopy system. These endoscopes are designed to increase user comfort, facilitate scope handling, and accommodate users with small hands. The ErgoGrip control section of these endoscopes is 10% lighter than Olympus’ previous generation.

Features of the EVIS X1 Endoscopy System include:

  • Texture and Colour Enhancement Imaging (TXI) technology: It is intended to improve image color and texture during endoscopic screening to increase the visibility of lesions and polyps. The Red Dichromatic Imaging (RDI) technology is intended to make deep blood vessels and bleeding points more visible.
  • Brightness Modification: The Imaging with Maintenance of Contrast (BAI-MAC) technology is intended to increase the overall field of view by adjusting the brightness levels in dark areas of the endoscopic image while maintaining the brightness of lighter areas. The EVIS X1 endoscopy system continues to use Narrow Band Imaging (NBI) technology. NBI technology makes use of specific blue and green wavelengths that are absorbed by hemoglobin to improve visual observation of mucosal and vascular patterns.
  • Streamline processes: The CV-1500 video system center’s touch panel enables users to start all processes, change all settings, and manage image data from a single device.
  • MyCV mode: Using a single scope button, a doctor can customize imaging configurations and toggle several features on and off.

The use of TXI, RDI, BAI-MAC, and NBI technologies is not meant to take the place of histopathological sampling in the diagnosis process. These are auxiliary instruments that can be used in conjunction with Olympus white light imaging during an endoscopic examination.

“Olympus is thrilled to bring our most advanced endoscopy system to GI practitioners in the U.S.,” said Richard Reynolds, President of the Medical Systems Group for Olympus America, Inc. Richard mentioned, “The remarkable new technologies for visualizing the GI tract are designed to help physicians see more and do more to help their patients.”

According to DelveInsight’s “Endoscopes Market” report, the global endoscopes market was valued at USD 12.95 billion in 2022, growing at a CAGR of 6.05% during the forecast period from 2023 to 2028 to reach USD 18.32 billion by 2028. The increase in demand for endoscopes is primarily attributed to the increasing prevalence of chronic diseases that require the use of endoscopes for diagnoses, such as some gastrointestinal diseases like irritable bowel syndrome (IBD), gastroesophageal reflux disease (GERD), peptic ulcer disease, and Crohn’s disease, increase in several geriatric populations who are more prone to chronic ailments, increasing awareness and demand of minimally invasive surgeries and no blood loss surgery, and rise in technological advancements in endoscopes like image magnification, high-definition optical systems and digital imaging are anticipated to bolster the market, thereby contributing to the growth of the endoscopes market during the forecast period from 2023-2028.

Cardio Flow, Inc. Announced the US Food and Drug Administration (FDA) 510(k) Clearance for FreedomFlow® Orbital Atherectomy Peripheral Platform

On October 18, 2023, Cardio Flow, Inc., a private medical device company focussing on the development of minimally invasive devices to treat peripheral artery disease (PAD), announced the US Food and Drug Administration (FDA) 510(k) clearance for its FreedomFlow Orbital Atherectomy Peripheral Platform.

A contemporary mechanism of action is built into the FreedomFlow platform to remove plaque blockages from the arteries in the legs. Five diamond-coated spheres are simultaneously in contact with the vessel wall thanks to the spiral geometry created by this unique catheter-based design, which makes use of the laws of angular momentum. Additionally, a driveshaft with a diamond-coated tip can more easily pass through obstacles.

With this innovative method, doctors have a highly effective, flexible, and efficient way to treat complex PAD in a variety of vessel diameters, ranging from 2 mm in the ankle to 8 mm in the hip. They also have more flexibility in treating multiple arteries and multiple blockages in the same vessel with a single device.

The FreedomFlow platform’s simplicity also saves time and money because it requires little to no capital equipment, lubricant, or inventory, and it is easy to set up devices quickly and easily. It offers the perfect option for current hospitals, outpatient surgery centers, and office-based labs because it also offers quicker run times, consistent treatment results, and a nearly flat learning curve for medical professionals.

Dr. Thomas Davis, M.D., the Director of Cardiovascular Research at Ascension St. John’s Hospital in Detroit, MI, and a recognized leader in the treatment of PAD and critical limb-threatening ischemia, commented, “The incidence of patients presenting with multi-level PAD has increased dramatically in my practice, so having a flexible, efficient, and easy-to-use device that can treat PAD in a broad range of vessel sizes is a key advantage for physicians and patients as we seek to reduce the number of PAD-related amputations.”

Michael J. Kallok, Ph.D., CEO of Cardio Flow, stated, “Cardio Flow is committed to providing meaningful solutions that directly address the needs of physicians and their PAD patients through innovative product development. Many of the existing atherectomy devices on the market have various design constraints and capital equipment costs. With FreedomFlow, we strove to provide physicians with the freedom to treat complex PAD hip to heel with a simple yet sophisticated device that would answer the call for flexible treatment options and cost savings for healthcare systems. We’re excited that FreedomFlow will now be available to physicians.”

As per DelveInsight’s “Peripheral Artery Diseases Market” report, the global peripheral artery disease (PAD) market was valued at USD 3,757.64 million in 2022, growing at a CAGR of 6.64% during the forecast period from 2023 to 2028 to reach USD 5,469.02 million by 2028. The peripheral artery disease (PAD) market is observing remarkable market growth due to factors such as the escalating burden of the geriatric population and the rising prevalence of peripheral artery disease (PAD) and arteriosclerosis across the globe. Further, the rising prevalence of obesity, diabetes, and high blood pressure, increasing product launches and approvals, and others will create a necessity for peripheral artery disease (PAD) in the market. Therefore, the market for peripheral artery disease (PAD) is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

GE Healthcare and Novo Nordisk Collaborated to Advance Novel Non-Invasive Treatment for Type 2 Diabetes and Obesity with Ultrasound

On October 19, 2023, GE HealthCare announced a collaboration with Novo Nordisk to further advance the clinical and product development of peripheral-focused ultrasound (PFUS). The novel technology is expected to have the potential to specifically regulate bodily metabolic function using ultrasound and may assist in the treatment of chronic diseases such as type 2 diabetes and obesity.

Around the world, 540 million adults are estimated to have diabetes, with type 2 diabetes constituting more than 90% of all cases. By 2045, it is predicted that one in eight people will have diabetes, with low- and middle-income nations bearing a disproportionately heavy burden of the disease. Type 2 diabetes is a significant public health burden due to its effects on mortality and quality of life, as well as the fact that it has been on the rise alarmingly over the past three decades. Approximately 1 billion people worldwide suffer from obesity.

Using ultrasound to activate the nervous system and potentially treat disease, PFUS is a non-invasive form of bio-electronic medicine. Personalized ultrasound stimulation of nerve pathways may affect glucose metabolism in people with diabetes, according to preliminary early-stage clinical research and pre-clinical proof of concept. PFUS might be a non-pharmacologic strategy to normalize blood glucose levels in people with type 2 diabetes if it is supported by additional clinical evidence. A group of scientists at the former GE Research Centre, now known as GE HealthCare’s HealthCare Technology and Innovation Centre, created the current technology.

GE HealthCare and Novo Nordisk will collaborate to develop a PFUS solution to enhance patient care, building on the extensive foundational research completed to date by the GE HealthCare team, using their respective expertise in ultrasound medical technology and metabolic disease treatment and management. The agreement’s other details weren’t made public.

“In an era where diabetes is increasing around the globe, we are enthusiastic about the potential for ultrasound to help people live healthier lives,” said Roland Rott, President and CEO, Ultrasound, GE HealthCare. Roland added, “This collaboration with Novo Nordisk opens a path to evolve ultrasound from a means of screening and diagnosis into therapy, as well. We are eager to validate and further develop this potentially groundbreaking science, as we strive to offer patients alternative treatment options for chronic diseases.”

“We look forward to exploring the potential impact this technology could have on treating people with type 2 diabetes and obesity, as significant unmet needs remain in these diseases in spite of recent advances in care,” said Martin Holst Lange, Executive Vice President and Head of Development at Novo Nordisk. Martin commented, “Although early, the possibilities of using ultrasound for therapeutic purposes are compelling and we welcome our collaboration with GE HealthCare in this truly novel area.”

According to DelveInsight’s “Ultrasound Devices Market” report, the global ultrasound devices market was valued at USD 6.76 billion in 2022, growing at a CAGR of 6.82% during the forecast period from 2023 to 2028 to reach USD 10.05 billion by 2028. The ultrasound devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early disease detection, and increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the ultrasound devices market during the forecast period. (2023-2028). 

Medtronic Received FDA approval for Aurora EV- ICD system to treat arrhythmias

On October 24, 2023, Medtronic received FDA approval for its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD) MRI SureScan system.

The Epsila EV MRI SureScan defibrillation lead and the Aurora EV-ICD system were both approved by the US regulatory body. The goal of the defibrillator and defibrillation lead is to treat extremely fast heart rhythms (arrhythmias) that could cause sudden cardiac arrest.

Using its proprietary PhysioCurve design, Medtronic created the Aurora EV-ICD system to be identical in size, shape, and durability to traditional transvenous ICDs. It offers the same advantages as conventional ICDs, such as Pause-Prevention Pacing and Anti-tachycardia Pacing (ATP) using low-energy pacing pulses. The Aurora device will also provide extra advantages from Smart Sense, a cutting-edge algorithm created to lessen the possibility of unwarranted shocks. 

In contrast to conventional ICDs, the system is implanted using a minimally invasive technique in the left mid-axillary region (below the left armpit), with the lead being placed under the sternum. In the upcoming weeks, the global healthcare technology company plans to start a limited commercialization of the Aurora EV-ICD system in the US.

The outcomes of a large-scale clinical trial supported the FDA approval, which covers the Aurora EV-ICD system and its distinctive procedure implant tools.

In a study conducted at 46 locations across 17 countries with 356 patients at risk of sudden cardiac death, the safety and efficacy of the Medtronic EV ICD system were assessed.

According to the study, the device delivered the defibrillation therapy with 98.7% accuracy at the time of implant.

Medtronic Cardiac Rhythm Management business chief medical officer Alan Cheng said: “This FDA approval paves the way for patients to have a better overall experience with ICD therapy. ICDs remain the gold standard for the prevention of sudden cardiac death, and while the subcutaneous ICD avoids certain complications associated with transvenous defibrillators, it has limitations that may affect a patient’s comfort and quality of life. With the Aurora EV-ICD system, patients can benefit from the only ICD placed outside the vascular space that provides ATP and backup pacing, in a device that is nearly half the size and with 60% greater projected battery longevity compared to the competitor’s subcutaneous ICD.”

According to DelveInsight’s “Defibrillators Market” report, the global defibrillators market was valued at USD 10.19 billion in 2022, growing at a CAGR of 3.11% during the forecast period from 2023 to 2028, to reach USD 12.24 billion by 2028. 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.

Medtronic Evolut™ TAVR platform outperformed surgery with sustained valve performance for low-risk patients at four years

On October 24, 2023, Medtronic, the leader in healthcare technology, released its four-year findings of the Evolut Low-Risk Trial. In comparison to surgical aortic valve replacement (SAVR), the Medtronic Evolut transcatheter aortic valve replacement (TAVR) system demonstrated exceptional results and sustained valve performance. Only Evolut TAVR has consistently reported lower and diverging rates of death or disabling stroke at four years compared to cutting-edge surgery. Since TAVR was approved for use in low-risk surgical patients, more data is still required to fully comprehend the short-, medium–, and long-term durability of TAVR devices of various designs.

A prospective, randomized, multicenter, international, noninferiority study called the Evolut Low-Risk Trial was conducted to compare the safety and effectiveness of the Evolut TAVR system to surgical aortic valve replacement (SAVR) in low-risk patients. Low-risk patients were randomized to TAVR with a Medtronic self-expanding, supra-annular Evolut R, PRO, or CoreValve bioprosthesis vs. SAVR. Low-risk patients were defined in the trial as having a predicted risk of 30-day mortality of 3%. A total of 1,414 patients (730 TAVR and 684 SAVR) underwent attempted implants.

The primary endpoint of all-cause mortality or disabling stroke continued to show positive results for Evolut TAVR at four years compared to SAVR. When TAVR (10.7%) was used instead of SAVR (14.1%), the risk of death or a disabling stroke was reduced by 26% (p=0.05) at four years. In terms of the primary endpoint, the absolute difference between the treatment arms grew over time, showing that Evolut TAVR provided patients with a clinical advantage over surgery at four years. Additionally, the results revealed that with TAVR, the composite of all-cause mortality, disabling stroke, or aortic valve re-hospitalization was 18.0%, and with SAVR, it was 22.4% (p=0.04).

“As we see patients in the Evolut Low-Risk trial continue to show positive outcomes and sustained valve performance compared to surgery out to four years, this helps us establish intermediate-term evidence for Evolut TAVR and helps define what this might look like in the long term,” said Dr. Michael Reardon, Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital and principal investigator of the trial. Dr. Michael stated, “These results are not only encouraging but pivotal in shaping treatment decisions for low-risk patients with symptomatic severe aortic stenosis. We are seeing sustained, excellent valve performance in patients treated with Evolut TAVR, which ultimately translates into improved outcomes, including mortality and disabling stroke. This intermediate-term result underscores the belief that valve design matters, and previously published data points to superior outcomes and better design in the Evolut TAVR platform.”

“The Medtronic Low-Risk data presented today at TCT demonstrates our continued commitment to generating evidence on our Evolut TAVR platform and providing treatment options for low-risk symptomatic severe aortic stenosis patients, a growing patient population,” said Nina Goodheart, senior vice president and president of the Structural Heart & Aortic business within the Cardiovascular Portfolio at Medtronic. Nina added, “We are dedicated to supporting advanced, lifelong patient care by empowering physicians with the latest minimally invasive, clinically proven technology to best treat their patients.”

According to DelveInsight’s “Transcatheter Aortic Valve Devices Market” report, the global transcatheter aortic valve devices market was valued at USD 3.23 billion in 2022, growing at a CAGR of 15.41% during the forecast period from 2023 to 2028 to reach USD 7.64 billion by 2028. The demand for transcatheter aortic valve replacement devices is primarily being boosted by the increasing prevalence of aortic stenosis disorder, rise in cardiovascular disorders, increasing demand for TAVR procedures, increasing prevalence of aortic regurgitation and the technological advancements pertaining to the transcatheter aortic valve replacement arena which are expected to increase in the product demand thereby contributing in the growth of the transcatheter aortic valve replacement devices market during the forecast period from 2023-2028.

Late-Breaking Data Showcase the Benefits of Abbott’s Minimally Invasive Devices for People with Leaky Heart Valves

On October 24, 2023, Abbott announced data from late-breaking presentations showing the impact of minimally invasive heart devices in treating mitral and tricuspid valve disease. The TriClip trans-catheter edge-to-edge repair system is safe and effective for treating patients with symptomatic, severe tricuspid regurgitation (TR) despite receiving optimal medical therapy, according to data from the pivotal TRILUMINATE trial.

The business also disclosed recently released information from the MitraClip EXPAND G4 real-world registry that demonstrates the advantages of the device for a wide range of patients with mitral regurgitation (MR).

People with MR and TR may have leaky valves, which can cause less blood to be pumped through the body and extra work for the heart. Consequently, MR and TR can cause additional cardiovascular problems and significantly reduce a person’s quality of life. While historically surgery was frequently required to treat MR and TR, Abbott’s minimally invasive range of structural heart devices has made it possible to treat more patients globally effectively without running the risk of postoperative complications.

At the 35th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in San Francisco (October 23–26, 2023) the following studies utilizing goods from Abbott’s market-leading structural heart portfolio were presented.

TriClip TRILUMINATE Pivotal Trial Data:

The TRILUMINATE pivotal trial is the first randomized, controlled clinical study to compare medical therapy for severe TR patients with transcatheter repair using the TriClip system for safety and efficacy. The device’s safety, effectiveness, and advantages were demonstrated at TCT by the results to date for all randomized patients (N=572) and those enrolled in the concurrent single-arm group (patients with more complex tricuspid valve anatomy).

The following are significant results from the pivotal TRILUMINATE trial after a year:

TriClip therapy showed significant improvements in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms, and quality of life) for the full randomized group, along with an excellent safety profile, supporting and supporting the findings in the primary randomized population (N=350, presented at ACC 2023).

The single-arm group with more intricate anatomy and more severe disease achieved its main goal. With 81% of patients achieving TR reduction to moderate or less and reporting a comparable degree of KCCQ improvement to the randomized population, the data showed that TriClip was safe.

“The updated TRILUMINATE pivotal results confirm what has previously been shown – that TriClip is safe and effective for patients with severe tricuspid regurgitation,” said David Adams, M.D., chairman of the Department of Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai and cardiac surgeon-in-chief of the Mount Sinai Health System, who served as co-primary investigator of the trial. David mentioned, “With the addition of the single-arm data that include people with more complex tricuspid anatomies, the takeaway is that TriClip is reducing TR effectively and patients are subsequently experiencing improvement in their quality of life.”

MitraClip: EXPAND G4 Study One-Year Results:

The EXPAND G4 study confirms the safety and efficacy of the MitraClip G4 system in patients with a wide range of anatomies. It is a prospective, multi-center, international, real-world study involving more than 1,100 patients.

At one year, the EXPAND G4 study’s major conclusions are as follows:

The majority of patients (93%) achieved an MR reduction to mild or less (grade 1+ on a five-point scale), and 44% of patients achieved an MR reduction to trace or less, which is the highest reported MR reduction in a mitral TEER study to date.

Significant clinical improvements included a 19-point increase in the KCCQ score and 82% of patients achieving New York Heart Association (NYHA) Functional Class I/II (meaning they reached a point of minimal or no limitation of physical activity), up from 36% at baseline.

In a global, real-world mitral TEER study, MitraClip demonstrated the lowest rates of all-cause mortality (12%) and heart failure hospitalization (17%).

“These late-breaking data at TCT offer further evidence that our innovative, minimally-invasive heart devices are having a positive impact on the lives and well-being of those with structural heart disease,” said Michael Dale, senior vice president of Abbott’s structural heart business. Michael added, “For more than two decades, Abbott has continued to evolve and expand its minimally invasive treatment options for mitral and tricuspid regurgitation. Our portfolio of technologies to restore health and improve the quality of life of patients with leaky valves represents new standards of care and an example of our commitment to leadership in the treatment of structural heart disease.”

According to DelveInsight’s “Transcatheter Heart Valve Replacement Devices Market, report, the global transcatheter heart valve replacement market is estimated to grow at a CAGR of 13.75% during the forecast period from 2023 to 2028. The transcatheter heart valve replacement market is observing significant market growth, primarily owing to the growing number of valvular heart diseases and aortic stenosis disorders across the globe. Further, the rising focus on minimally invasive surgeries, increasing technological advancements in device & surgical procedures, the increasing burden of the geriatric population prone to aortic stenosis, mitral regurgitation, and other cardiovascular disorders, increasing burden of risk factors leading to valvular diseases, presence of a large number of devices in the pipeline, increasing product launches and approvals, surging investments by key players, among others will ultimately affect the demand for transcatheter heart valve during the forecast period from 2023-2028 growing at a substantial CAGR.