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FDA Approved IDE for Picso® Pivotal Study of Miracor Medical
On August 23, 2022, Miracor Medical SA, a provider of innovative solutions for the treatment of severe cardiac diseases, announced that the FDA has approved an Investigational Device Exemption (IDE), allowing the company to begin a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology.
The PiCSO-AMI-II multicenter, randomized trial will enroll 300 patients with anterior ST-segment elevation myocardial infarction (STEMI) who have TIMI flow 0, 1, or 2 within 12 hours of symptom onset. At 5 days, the primary efficacy endpoint will be infarct size as measured by cardiac magnetic resonance imaging (CMR). At 30 days, the primary safety endpoint is a performance goal for device and procedure-related adverse events. Major adverse cardiac events and heart failure endpoints will be monitored for up to three years.
PiCSO-AMI-II will be the second major randomized trial to assess the role of PiCSO in improving coronary microvascular function and reducing infarct size in patients with anterior STEMI. Miracor is currently recruiting 144 patients for PiCSO-AMI-I, a ground-breaking European randomized controlled trial with endpoints comparable to the approved US trial. The European study’s recruitment is expected to conclude this summer. A future patient-level pooled meta-analysis of the two studies is expected to show a hard clinical endpoint improvement in heart failure hospitalization.
PiCSO is used as an adjunctive procedure after the epicardial flow has been restored during the primary percutaneous coronary intervention (PCI) procedure.
“Reducing infarct size and MVO is a key factor in improving survival and reducing the risk of heart failure among patients with a heart attack. PiCSO therapy is a promising new therapy to reduce infarct size and improve outcomes in anterior STEMI patients. The FDA-approved randomized IDE trial has been designed to validate the safety and effectiveness of PiCSO.” said Prof. Gregg W. Stone, Director of Academic Affairs for the Mount Sinai Heart Health System, New York, NY, USA.
Olivier Delporte, the CEO, said, “In addition to the ICD-10-PCS code that was granted by the Centers for Medicare and Medicaid Services (CMS) in April 2022, the Investigational Device Exemption marks a key milestone in the company’s lifecycle and speaks to the positive evolution of the company. We look forward to conducting a meticulous study with our clinical investigators to bring PiCSO to American patients.”
As per DelveInsight’s “Coronary Stents Market” report, the global coronary stents market was valued at USD 9.27 billion in 2021, growing at a CAGR of 7.51% during the forecast period from 2022 to 2027 to reach USD 14.28 billion by 2027. The demand for coronary stents is primarily being boosted by the increasing prevalence of cardiovascular diseases such as stroke, atherosclerosis, heart attack, and others, the increasing geriatric population across the globe, the growing number of percutaneous coronary intervention procedures, the increase in demand of minimally invasive surgeries, and the technological advancements in the coronary stents arena which are expected to cause an increase in the product demand thereby contributing in the growth of the coronary stents market during the forecast period from 2022-2027.
Oticon Announced the Launch of One of the World’s Smallest Hearing Aid with Brainhearing™ Technology
On August 24, 2022, Oticon, Inc., a hearing aid manufacturer, announced the launch of Oticon Own™, a new family of custom hearing aids.
Oticon Own is a fully customized in-the-ear hearing solution designed for maximum discretion and superior sound quality. Oticon Own is the world’s first custom in-the-ear hearing aid with an onboard Deep Neural Network that works more like the brain because it is learned through experience, leveraging the power of Oticon’s ground-breaking BrainHearingTM technology.
Oticon Own is the world’s first hearing aid with an embedded Deep Neural Network (DNN). The DNN was trained on 12 million real-life sounds to support the brain by providing access to important sounds in one’s environment. Even in complex listening environments like restaurants and office meetings, Oticon Own assists in navigating what needs to be heard, reducing listening effort and making it easier to focus on other tasks.
Oticon Own is developed to give access to the full sound environment, allowing the brain to work more effectively and naturally to make sense of sounds. It is based on the core of Oticon’s life-changing technology, BrainHearing.
Oticon Own is designed for easy connection to a wide range of devices, including two-way, hands-free communication with select iPhone® and iPad® devices and direct streaming from select AndroidTM devices. Oticon Own also provides users with direct, high-quality streaming, allowing them to easily stay connected with friends and family while listening to their favorite music with simple, discrete control.
“Oticon Own features life-changing technology that captures the power of BrainHearing to provide a personalized listening experience that allows people with hearing loss to focus on what matters most, with complete confidence,” said Oticon President Gary Rosenblum.
According to DelveInsight’s “Hearing Aid Devices Market” report”, the global hearing aid devices market was valued at USD 7.01 billion in 2021, growing at a CAGR of 5.47% during the forecast period from 2022 to 2027, to reach USD 9.61 billion by 2027. The hearing aid devices market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of hearing loss across the globe coupled with the rising geriatric population. Moreover, an increase in exposure to high-frequency sounds leading to noise-induced hearing loss could also augment the hearing aids growth. Further, increasing product development activities for hearing aid devices will also propel the market of hearing aid devices in the upcoming years.
UltraSight Announced the CE Mark for Novel Cardiac AI Technology
On August 25, 2022, UltraSight, an Israeli-based digital health pioneer transforming cardiac imaging with the power of artificial intelligence, announced that its AI-guidance software for cardiac ultrasound has received a CE Mark.
The UltraSight technology enables medical professionals to successfully capture diagnostic quality ultrasound images of the heart, regardless of their sonography experience. The technology can be used at the point of care, paving the way for more widespread detection of cardiovascular disorders and improving access to optimized cardiac care across the continent.
The novel Artificial Intelligence software works in tandem with existing point-of-care ultrasound devices to provide the operator with real-time instructions on how to capture high-quality diagnostic images. Based solely on the ultrasound video stream, the Artificial Intelligence neural network predicts the position of the ultrasound probe relative to the heart and guides the user on how to maneuver the probe to ensure that the acquired images are of diagnostic quality.
The UltraSight AI Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients. It is intended to assist medical professionals in performing cardiac ultrasound scans. UltraSight Artificial Intelligence Guidance software is an accessory to compatible general-purpose diagnostic ultrasound systems and is intended to be used by medical professionals who have received UltraSight’s training as described in the user manual.
UltraSight received CE Mark after clinical study results at Israel’s Sheba Medical Center validated its technology and confirmed that the software is effective at instructing novice medical professionals to acquire diagnostic-quality cardiac images. According to the study, UltraSight AI guidance enabled medical professionals with no prior sonography experience to obtain diagnostic quality cardiac images in 100% of patients.
“UltraSight was founded to apply the power of machine learning in imaging and put the ability to scan patients into the hands of physicians everywhere,” said Davidi Vortman, CEO of UltraSight. Vortman added, “By empowering more medical professionals to accurately scan patients, we will have faster and greater detection of CVD across the continent. This is not only a momentous occasion for UltraSight as a company, but it brings us one step closer to helping the millions of people in Europe who suffer from CVD.”
According to DelveInsight’s “Cardiovascular Ultrasound System Market” report, the global cardiovascular ultrasound system market was valued at USD 1.61 billion in 2021, growing at a CAGR of 4.79% during the forecast period from 2022 to 2027, to reach USD 2.11 billion by 2027. The increase in demand for cardiovascular ultrasound systems is predominantly attributed to the spike in cardiovascular cases worldwide. In addition, the growing geriatric population, increase in sedentary lifestyles, and rising government initiatives to raise awareness regarding early detection and management of cardiovascular disorders among patients, are anticipated to drive the global cardiovascular ultrasound system market during the forthcoming years.
Medtronic Extravascular ICD Meets Global Pivotal Clinical Trial’s Safety and Effectiveness Endpoints
On August 28, 2022, Medtronic plc, a global leader in healthcare technology, announced that in a global clinical trial, its investigational EV ICDTM System – a first-of-its-kind defibrillator with the lead placed under the breastbone, outside of the heart and veins – achieved a defibrillation success rate of 98.7% and met its safety endpoints.
The EV ICD Pivotal study was a prospective, multicenter, single-arm, non-randomized, pre-market clinical trial that evaluated the safety and efficacy of the Medtronic EV ICD system in patients at risk of sudden cardiac death. The EV ICD Pivotal study enrolled 356 patients across 17 countries with 46 sites in North America, Europe, the Middle East, Asia, Australia, and New Zealand. Medtronic has been granted FDA permission to conduct a Continued Access Study while the agency evaluates the company’s EV ICD pre-market application.
As the lead (thin wire) of the device is placed outside the heart and veins, under the breastbone (sternum), using a minimally invasive approach, the Medtronic EV ICD system is designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). The placement of the lead in this location is intended to reduce the risk of long-term complications associated with leads in the heart and veins, such as vessel occlusion and blood infection risks.
The lead is connected to a device that is implanted below the left armpit. Clinical trial participants received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing (ATP), and backup pacing therapies with this single implanted device that is similar in size, shape, and longevity to traditional ICDs.
- Effectiveness: The device’s effectiveness in delivering defibrillation therapy at implant was 98.7% (298 of 302 patients) in the study, exceeding the predefined performance goal of 88%. These findings show that the EV ICD has higher defibrillation efficacy than previous Trans venous ICD studies; comparable efficacy to the subcutaneous ICD despite the EV ICD’s smaller device size; and a predicted increase in longevity compared to the subcutaneous ICD. Furthermore, all discrete spontaneous arrhythmias (18 of 18, 100%) were successfully treated. Furthermore, the efficacy of ATP in the EV ICD study was comparable to ATP efficacy in trans venous defibrillators.
- Safety: The study also exceeded its safety endpoint: 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 (compared to the performance goal of 79%; p<0.001). There were no major intraprocedural complications, nor any unique complications observed related to the EV ICD procedure or system (compared to transvenous and subcutaneous ICDs).
“These pivotal data mark the start of a new era in ICD therapy for patients who are at significant risk of dangerously fast heart rhythms,” said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. He added, “Today’s findings are an important clinical milestone toward our goal of delivering a one-system, one-procedure extravascular ICD solution that prevents sudden cardiac arrest while improving the patient experience with a smaller device and moving the lead out of the veins and placing it under the breastbone. The EV ICD system retains the benefits of a completely extravascular system while providing ATP, pause prevention pacing, and low defibrillation energy.”
According to 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 a defibrillator is primarily associated with the growing number of cardiac disorders, integration of advanced technology, increasing investments by government and private manufacturers, and the rising awareness programs regarding cardiovascular disorders, and usage of defibrillators, among others. As per DelveInsight’s Analysis, in the defibrillator market by product type, implantable cardioverter defibrillator (ICD) is expected to hold the largest share in the market as there are different types of ICD such as one chambered, dual-chambered, subcutaneous chambered, and magnetic resonance imaging (MRI), one of the safe ICD in the market.
Galaxy Medical Receives CE Mark for CENTAURI Pulsed Electric Field System
On August 29, 2022, Galaxy Medical announced that it has received the CE Mark for its CENTAURI Pulsed Electric Field (PEF) System and has begun its commercialization process.
The approval enables the company to market the system for the treatment of paroxysmal atrial fibrillation (AF) in the European Union and other countries where the CE Mark is accepted.
PEF treats arrhythmias by delivering high-voltage, high-frequency bursts of energy. CENTAURI is the first commercially available system that allows PEF ablation with focal catheters, which are used in the vast majority of cardiac ablation procedures around the world.
CENTAURI has several unique features:
- The CENTAURI Connect module allows physicians to perform PEF ablation procedures with marketed focal catheters and mapping systems without adjustments to workflow or the typical learning curve of training on new catheters.
- The focal catheter energy is delivered in a monopolar fashion, creating more consistent and deeper lesions.
- The proprietary WAVE1 waveform eliminates microbubbles observed with other PEF ablation products that can cause brain lesions and strokes, enabling monopolar energy delivery without significant muscle contraction.
- CENTAURI offers three energy settings, allowing physicians to choose dosing specific to the target tissue
“From the beginning, we designed CENTAURI to be the workhorse PEF system for all electrophysiology labs, enabling physicians to maintain use of their favored mapping systems and catheters,” commented Jonathan Waldstreicher, MD, CEO of Galaxy Medical. He added, “Our goal is to provide a safer and more effective alternative to thermal ablation for all practitioners of cardiac arrhythmia ablation, and the CE Mark allows us to offer CENTAURI to electrophysiologists broadly.”
According to DelveInsight’s “Cardiac Ablation Devices Market” report, the global cardiac ablation devices market was valued at USD 2.25 billion in 2021, growing at a CAGR of 12.77% during the forecast period from 2022 to 2027, to reach USD 4.63 billion by 2027. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Further, growth in new therapies, technological advancements, increasing geriatric population, and penetration and acceptance of cardiac ablation devices in emerging countries will drive market growth. Cardiac ablation devices were found to be extremely beneficial in heart failure cases in COVID-19 which further pushed the demand for these devices during the pandemic situation.
Medtronic Completes Acquisition of Affera
On August 30, 2022, Medtronic plc, a global leader in healthcare technology, announced the completion of its acquisition of Affera, Inc., a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing cardiac arrhythmia market.
This acquisition broadens the company’s cardiac ablation portfolio by adding its first-ever cardiac mapping and navigation platform, which includes a distinct, fully integrated diagnostic, focal pulsed field, and radiofrequency ablation solution.
The investigational Affera technology is intended to help patients suffering from cardiac arrhythmias (irregular heartbeats) such as atrial fibrillation (AF). Medtronic gains the Affera Prism-1TM cardiac mapping and navigation platform through this acquisition, which will be compatible with Medtronic as well as multiple competing therapeutic catheters and technologies.
The Sphere-9TM cardiac diagnostic and ablation catheter, which enables the rapid creation of detailed electro-anatomical maps and provides radio frequency (RF) and pulsed-field (PF) cardiac ablation therapies, is also available from the company. Other Affera pipeline products include the Arc-10 coronary sinus (CS) diagnostic catheter and the Sphere PVI ablation catheter, a single-shot device that delivers pulsed field ablation (PFA) energy.
The full suite of Affera solutions and technologies will complement Medtronic’s existing atrial and ventricular arrhythmia disease management portfolio and support the company’s efforts to provide differentiated, safe, and effective cardiac ablation solutions. The prevalence of cardiac arrhythmias such as AF, supraventricular tachycardia (SVT), and ventricular tachycardia (VT) is rapidly increasing. AF is the most common disease, affecting nearly 60 million people worldwide.
“This acquisition marks an important growth milestone for our cardiac ablation portfolio,” said Rebecca Seidel, president of the Cardiac Ablation Solutions (CAS) business, which is part of the Cardiovascular Portfolio at Medtronic. Rebecca Seidel said, “We’re incredibly proud to have led the industry with the introduction of the proven safe and effective cryoablation technology, and now these new additions to our portfolio help support a leap forward in our commitment to build a comprehensive portfolio and help physicians achieve the best outcomes for patients.”
“The Affera team is very excited to be joining Medtronic Cardiac Ablation Solutions. The acquisition enhances and accelerates our ability to treat millions of patients around the world suffering from cardiac arrhythmia with our innovative technology,” said Doron Harlev, founder and chief executive officer of Affera. He commented, “Our team designed the Affera platform with physicians and patients in mind, to advance the field of electrophysiology while supporting safe and efficient cardiac ablation procedures.”
According to DelveInsight’s “Cardiac Arrhythmia Monitoring Devices Market” report, the global cardiac arrhythmia monitoring devices market is estimated to grow at a CAGR of 6.33% during the forecast period from 2022 to 2027. Factors such as the increasing incidence of cardiovascular cancers, rising expenditure on cardiac health, rising adoption of mobile and telemetry cardiac monitors, rising prevalence of cardiac arrhythmias, and others are expected to bolster the demand for these services 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 cardiovascular disorders in the region and the increasing launches of products of the cardiac arrhythmia monitoring devices market.