Apr 17, 2025
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On April 14, 2025, Edwards Lifesciences Corporation announced that its SAPIEN M3 mitral valve replacement system had received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who were considered unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy. Building on the company’s established SAPIEN technology, the SAPIEN M3 became the world’s first approved transcatheter valve replacement therapy to utilize a transfemoral approach for treating MR.
“Edwards’ 65-year legacy of structural heart innovation is firmly rooted in transforming care for underserved patient populations and the SAPIEN M3 system is built on the proven SAPIEN platform, which has been used in more than 8,000 procedures in the mitral position,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “We were the first to gain CE Mark for a transcatheter tricuspid valve replacement system, and with the SAPIEN M3 system’s approval, Edwards is now the only company providing a transcatheter portfolio that includes both replacement and repair treatment options for both the mitral and tricuspid valves, meeting the broad and diverse needs of these patients in Europe.”
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“Mitral regurgitation is the most common form of valvular heart disease and these patients suffer with debilitating and often life-threatening symptoms,” said Dr. Michael Mullen, Barts Heart Centre, St Bartholomew’s Hospital, London, UK. “The SAPIEN M3 system establishes a new pathway for care with its novel docking mechanism and transseptal access, providing an important new treatment option for patients unsuitable for surgery or TEER.”
The SAPIEN M3 system involved a two-step procedure: first delivering the dock, then the valve to fully replace the mitral valve. The dock wrapped around the native mitral leaflets, drawing them and the chordae toward the center, creating a stable landing zone for valve placement. Both components were delivered via a 29F steerable guide sheath through the femoral vein. Data showed a significant reduction in MR and improved quality of life. Edwards planned to present results from the ENCIRCLE pivotal trial in late 2025 and launched a European Post-Market Clinical Follow-up Study with five-year follow-up. The company’s CE Mark-approved mitral and tricuspid portfolio also included the PASCAL Precision and EVOQUE systems. The SAPIEN M3 had not yet been approved in the U.S.
As per DelveInsight’s “Transcatheter Mitral Valve Repair Devices Market Report”, the transcatheter mitral valve repair devices market was valued at USD 1,197.06 million in 2023, growing at a CAGR of 14.95% during the forecast period from 2024 to 2030 to reach USD 2,756.71 million by 2030. The transcatheter mitral valve repair devices market is expanding rapidly due to the growing prevalence of cardiovascular disorders including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter mitral valve repair devices market during the forecast period from 2024 to 2030.
On April 15, 2025, Terumo Neuro, a global leader in neurovascular innovation and a wholly owned subsidiary of Terumo Corporation, announced that its Carotid Stent System had received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). This achievement marked the first dual-layer micromesh carotid stent to be approved in the United States, providing physicians with a clinically proven option to enhance patient outcomes in the treatment of carotid artery disease.
The Carotid Stent System was indicated for the treatment of carotid artery stenosis in patients at increased risk of adverse events following carotid endarterectomy. It was designed to treat patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in the internal carotid arteries or at the carotid bifurcation, with ≥50% stenosis in symptomatic patients or ≥80% in asymptomatic patients, as confirmed by angiography. The device supported vessel reference diameters ranging from 3.5 mm to 9.0 mm at the target lesion.
As per DelveInsight’s “Carotid Artery Stent Market Report”, the global carotid artery stents market was valued at USD 575.76 million in 2023, growing at a CAGR of 3.21% during the forecast period from 2024 to 2030 to reach USD 718.25 million by 2030. The demand for carotid artery stents is primarily being boosted by the increasing prevalence of cardiovascular disorders such as stroke, ischemic stroke, and Transient Ischemic Attack (TIA), among others. Additionally, the increasing demand for minimally invasive surgical procedures is another key factor influencing the positive growth of the market. Further, rising technological developments in the domain of stents are also contributing to the overall growth of the Carotid Artery Stents market during the forecast period from 2024 to 2030.
On April 09, 2025, Microbot Medical Inc., the developer of the innovative LIBERTY® Endovascular Robotic System, presented data from its ACCESS-PVI pivotal trial for the first time at the Society of Interventional Radiology (SIR) annual meeting. The study had been conducted at three leading U.S. medical centers: Memorial Sloan Kettering Cancer Center (New York, NY), Baptist Hospital of Miami (Miami, FL), and Brigham and Women’s Hospital (Boston, MA). The late-breaking podium presentation was delivered by Francois Cornelis, M.D., PhD, Director of the Neuro Vascular Interventional Radiology Program at Memorial Sloan Kettering Cancer Center.
The ACCESS-PVI study demonstrated that robotic endovascular procedures using the LIBERTY® system were feasible and significantly reduced radiation exposure. In the study, successful robotic navigation was achieved in all 20 cases, resulting in a 100% success rate. No adverse device events occurred throughout the follow-up period. Radiation exposure was reduced by a mean of 92%, with a difference of -29.8 µS between the operator and control. The median robotic navigation time to target was 3 minutes, and physicians reported a 100% satisfaction rate with the LIBERTY® system.
“The ACCESS-PVI data and the performance of the system throughout the study reflect the hard work that the team has put into LIBERTY® over the past few years,” commented Harel Gadot, Chairman, CEO and President. “We are extremely pleased with the results in all aspects. As we shift focus to building our commercial capabilities and preparing for launch, we are confident that LIBERTY® will be well received in the market.”
“We are very satisfied with the clinical data, as well as with the investigators’ feedback in terms of the short learning curve and intuitive operation of the device,” commented Dr. Juan Diaz-Cartelle, the Company’s Chief Medical Officer. “We are looking forward to working with interventional physicians and staff upon FDA’s clearance.”
According to DelveInsight’s “Surgical Robotic System Market”, the global surgical robotic systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for Surgical Robotic Systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as increasing geriatric population who form a big part of at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the Surgical Robotic Systems market during the forecast period from 2024 to 2030.
On April 14, 2025, Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, announced the completion of the first cases in the clinical trial for the OTTAVA™ Robotic Surgical System. These cases marked the first clinical experience with the OTTAVA System.
Dr. Erik Wilson, Chief of Minimally Invasive and Elective General Surgery at UT Health Houston and the lead investigator for the clinical study, performed Roux-en-Y gastric bypass surgery using the OTTAVA Robotic Surgical System at Memorial Hermann-Texas Medical Center. “Surgical robotics is at the forefront of innovation in minimally invasive surgery,” Dr. Wilson said. “I am proud to have performed the first clinical study cases with OTTAVA and potentially help advance the standard in surgical robotics.”
“We are proud to reach this important milestone in our robotic surgery program,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “OTTAVA is a key innovation in our portfolio of advanced surgical technologies – all of which are designed to transform the surgical experiences across all surgery. Our people work side-by-side with surgical teams in ORs around the world every day to raise the standard of care for patients and deliver what’s next in surgery.”
The OTTAVA system had been developed as a versatile robotic platform for soft-tissue surgeries, capable of supporting a wide array of procedures across different anatomical regions and specialties, including intricate multi-quadrant operations.
Johnson & Johnson MedTech’s OTTAVA system received Investigational Device Exemption (IDE) approval from the U.S. FDA in late 2024. The system was designed to advance clinical innovation in general surgery, a key area within Johnson & Johnson MedTech’s broader surgical business. OTTAVA aimed to address the unmet needs that persisted in robotic surgery and to support complex procedures. Its unique unified architecture, surgical instrumentation developed with Ethicon expertise, and planned integration with the Polyphonic™ digital ecosystem were all intended to meet the specific needs of patients and the diverse clinical approaches of surgeons.
According to DelveInsight’s “Surgical Robotic System Market Report”, the global surgical robotic systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for Surgical Robotic Systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as increasing geriatric population who form a big part of at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the Surgical Robotic Systems market during the forecast period from 2024 to 2030.
On April 10, 2025, Baxter International Inc., a global leader in advancing surgical innovation, announced the introduction of the Hemopatch Sealing Hemostat with room temperature storage at a symposium in Austria. This product evolution optimized accessibility in the operating room, providing surgeons with an immediate solution to control bleeding or prevent leakage. It was made available for purchase across Europe.
“For over a decade, Hemopatch Sealing Hemostat has offered surgeons a reliable solution for tissue sealing, dura sealing, and hemostasis,” said Steve Wallace, president, Advanced Surgery at Baxter. “The product evolution to include room temperature storage is a result of close collaboration between surgeons and Baxter. Removing the need for refrigeration addresses the needs of our customers to have the product on hand in critical situations. We are proud to continue Baxter’s legacy of innovation in sealing and hemostasis.”
General Surgeon, Prof. Dr. med. Selman Uranüs said, “More than 10 years ago, I first used Hemopatch Sealing Hemostat for experimental testing. Since then, I have been using it in my daily practice because of its unique characteristics as a sealing hemostatic patch, especially in laparoscopic surgery. In my opinion, eliminating the need for refrigeration and increasing product shelf life are crucial improvements because it enable surgeons to have the product available in the operating room when it matters most. After application, the product shows an enhanced adhesive strength, supporting us surgeons to achieve better surgical outcomes.
Hemopatch Sealing Hemostat is a ready-to-use absorbable collagen pad intended for tissue sealing, dura sealing, and hemostasis, and was proven effective and safe for use in both open and minimally invasive surgeries. In a European registry of real-world data, the product demonstrated the ability to achieve rapid and sustained hemostasis across various surgical specialties.
According to DelveInsight’s “Surgical Sealant and Adhesives Market Report”, the global surgical sealant and adhesives market was valued at USD 2.18 billion in 2023, growing at a CAGR of 7.58% during the forecast period from 2024 to 2030 to reach USD 3.39 billion by 2030. The surgical sealant and adhesives market is slated to witness prosperity owing to the growing prevalence of chronic health problems such as cardiovascular problems, kidney problems, neurological issues, and others. The rise in road accidents requiring urgent surgeries is another factor in the growth of the surgical sealant and adhesives market. The continuous rise in cosmetic surgeries and growing focus on improving the safety, affordability, and usability of surgical sealants and adhesives are further expected to result in appreciable revenue growth in the Surgical Sealant and Adhesives Market during the forecast period 2024 to 2030.
On April 09, 2025, Merit Medical Systems, Inc., a global leader in healthcare technology, had revealed the US commercial release of its Ventrax Delivery System. This new delivery system was the latest addition to Merit’s growing electrophysiology (EP) and cardiac rhythm management (CRM) portfolio. The portfolio included a unique selection of solutions designed to enhance cardiac interventions, such as the HeartSpan®, Worley™, Prelude SNAP™, and SafeGuard Focus® product lines.
Ventrax is intended to facilitate the placement of devices used in ablation procedures commonly performed to treat an abnormally fast heartbeat known as ventricular tachycardia (VT). The all-in-one device provided a streamlined pathway for ablation catheters to enter the left ventricle through the aorta, a method known as retrograde aortic access.
“For the electrophysiologist, using retrograde aortic access was always a risk-benefit decision, and the community has needed a tool that would make that decision easier,” said Albert Sun, MD, electrophysiologist at Duke Health in Durham, NC, and whose advice was instrumental in Merit’s development of the Ventrax system.
“The new retrograde delivery system provides access to the left ventricle, allowing for the exchange of catheters to diagnose, map, or treat VT,” said Jason Koontz, MD, PhD, electrophysiologist at Duke Health and product development consultant to Merit. “This adds to our tools as we work to deliver the best possible outcomes for our patients.”
According to DelveInsight’s “Electrophysiology Devices Market Report”, the global electrophysiology devices market was valued at USD 6.31 billion in 2023, growing at a CAGR of 9.73% during the forecast period from 2024 to 2030, to reach USD 9.22 billion by 2030. The electrophysiology devices market is growing significantly due to the increasing cases of chronic disorders such as cardiovascular diseases including atrial fibrillation and coronary artery disease (CAD) with the rising shift towards minimally invasive approaches, innovative product developmental activities by leading companies, and rising geriatric population which are expected to escalate the to the overall growth of the electrophysiology devices market during the forecast period from 2024 to 2030.
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