The Latest Cardiac and Vascular News
ALWAY, Ireland–(BUSINESS WIRE)–Perfuze, a private medical device company dedicated to developing pioneering technology to treat acute ischemic stroke, proudly announces FDA clearance for the Millipede 070 Aspiration Catheter and the 2nd generation of the Millipede 088 Access Catheter. “Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximize their […]
SOUTH JORDAN, Utah, Dec. 18, 2023 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today outlined the ongoing succession planning process for its Chief Executive Officer (CEO). Pursuant to an Amended and Restated Employment Agreement, effective June 8, 2023, Merit […]
TEL AVIV, Israel, Dec. 18, 2023 (GLOBE NEWSWIRE) — ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy to treat a range of solid tumors, today announced the appointment of Eyal Morag, M.D., as Chief Medical Officer (CMO). Dr. Morag brings extensive experience as […]
FORT COLLINS, Colo., Dec. 18, 2023 (GLOBE NEWSWIRE) — Enlitic®, Inc., a leading innovator in data standardization, and INFINITT North America, a global enterprise imaging partner for medical institutions have entered into contractual arrangements in respect of licensing ENDEX™. This strategic commercial collaboration is aimed at advancing the standardization of […]
LUMA Vision, developer of a novel four-dimensional (4D) cardiac imaging and navigation platform, today announced a total of $22 million in new financing for the company. “Physicians require accurate, real-time data at the point of care in order to effectively treat patients” Post this The Series A3 financing added three […]
SHANGHAI, Dec. 17, 2023 /PRNewswire/ — YolTech Therapeutics today announced that the first patient has been dosed with YOLT-201, the company’s first in vivo genome editing candidate being developed as a single dose, potentially curative therapy for hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
The study by YolTech is a single-arm, open-label, dose-escalation clinical trial (Clinicaltrials.gov: NCT06082050). This trial’s primary objectives are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of YOLT-201 as well as the identification of an Optimal Biologically Active Dose (OBD).
ATTR-CM, a rare, progressive and debilitating disease. It is caused by the misfolding of unstable Transthyretin Protein (TTR), leading to the deposition of amyloid-like buildup in the myocardial interstitium, causing stiffening of the heart muscle and subsequent heart failure. Studies have reported the median survival time of approximately 3.5 years from the first diagnosis of ATTR-CM if left untreated.
Dr. Yuxuan Wu, Founder and CEO of YolTech, expressed, “The successful FPI in this trial is a significant milestone, representing YolTech’s relentless efforts in the field of in vivo gene editing are gradually becoming a reality. We extend our gratitude to all researchers, partners, and supporters involved in the YOLT-201 project, especially to the dedicated research team at FAHZU for their steadfast support of drug development in vivo gene editing. We believe through this therapeutic intervention, we will provide a novel treatment option for ATTR-CM patients, offering them new hope and an improved quality of life.”
This study is a part of YolTech’s series of clinical trials in vivo gene editing. The company remains committed to advancing research in the treatment of ATTR and other diseases. Through close collaboration with the clinical community, we will continue to pursue excellence, push the boundaries of medical technology, and provide more advanced and innovative medical solutions for patients worldwide.
About YOLT-201
YOLT-201 Injection utilizes several lipid components including ionizable lipids as primary excipients to encapsulate mRNA and sgRNA raw materials, forming lipid nanoparticles (LNP). Upon intravenous injection into the body, plasma ApoE protein binds to the surface of LNP particles. Liver cells expressing the LDLR receptor recognize ApoE protein and engulf the LNP through endocytosis, forming endosomes. The decrease in pH within endosomes promotes electrostatic interactions between ionizable lipids and endosomal membranes, leading to membrane disruption and the release of mRNA and sgRNA. mRNA, in the cytoplasm, binds to ribosomes, translating the base editor protein. The base editor protein, in combination with sgRNA, enters the cell nucleus. sgRNA specifically locates the base editor to the TTR gene sequence, and the base editor protein modifies the bases on the target TTR gene, preventing its normal transcription into mRNA. This process stops the production of the TTR protein, achieving the goal of a one-time administration for a comprehensive cure of ATTR diseases.
About YolTech
YolTech Therapeutics is a pioneering gene editing company dedicated to develop a robust gene editing medicines to treat patients with serious diseases, which has built leading high-throughput evolution platform and innovative LNP deliver system. It possesses strong capability of novel Cas and base editor discovery and exceptional in-house LNP production capacity for GMP manufactory, with independent intellectual property rights and core patent protection globally. It has created a pipeline with 10+ genetic medicines focusing on cardiovascular diseases, metabolic diseases, infectious diseases as well as more common and rare diseases. Leading asset will enter phase I trial by end of 2023.
For more information, please visit: www.yoltx.com
SOURCE YolTech Therapeutics
Caesarea, Israel – December 14, 2023 – Arineta Cardio Imaging, a leader in advancing cardiovascular imaging solutions through cutting-edge technology, installed its first SpotLight scanner in the U.S. at Connected Cardiovascular Care Associates (C3) in Dallas. Arineta ushers in this milestone along with the appointment of its new CEO, Douglas […]
SCOTTSDALE, Ariz., Dec. 13, 2023 – SimonMed Imaging (“SimonMed”), one of the largest outpatient medical imaging providers and radiology practices in the United States, recently unveiled new study data at the 2023 Radiological Society of North America’s Radiology Conference and Annual meeting. The original study evaluated the impact of Artificial […]
BRAINTREE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced it has entered into a collaboration agreement with Corewell Health™. The objective of the collaboration, which will take place in multiple phases, is to enable telerobotics […]
Safe, efficient, and effective treatment for both paroxysmal and persistent atrial fibrillationDUBLIN, Dec. 13, 2023 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF). This is the first PFA technology to receive FDA approval and follows the recent European CE (Conformité Européenne) Mark of the PulseSelect PFA system in November.
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PulseSelect
PulseSelect PFA System
“Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency1. It’s a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients,” said Rebecca Seidel, SVP and President of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio. “The PulseSelect PFA system, together with the CE Marked Affera™ mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence.”
The PulseSelect PFA system was engineered with differentiated safety features and provides rapid, effective pulmonary vein isolation (PVI) through consistent and predictable energy delivery and catheter maneuverability. The system is designed to enable a seamless transition to PFA in a clinician’s preferred workflow2. The PulseSelect PFA system’s safety, efficacy, and efficiency is supported by the PULSED AF study, which showed a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AF patients1.
“The PulseSelect PFA system ushers the EP community to a new era of safe, effective, and efficient AF ablation that overcomes many challenges in our current practice,” said Dr. Amin Al-Ahmad, clinical cardiac electrophysiologist at St. David’s Medical Center in Austin, TX and one of 67 global operators in the PULSED AF trial. “In my clinical experience with the catheter, it was designed for AF ablation procedures. The learning curve in using the catheter and system is short, and the catheter enables the operator to deliver fast and controlled pulsed field energy for AF ablation.”The PulseSelect PFA system also includes the following:
Designed as a plug-and-play system, PulseSelect can be used with any mapping system or with just fluoroscopy2.
Built-in safety features such as a phrenic nerve test pulse, a non-therapeutic low voltage pulse that provides a preemptive assessment of catheter proximity to the phrenic nerve prior to delivering a therapeutic application.
Fixed spacing for the nine-electrode catheter, which produces a predictable and consistent electric field for contiguous ablation2. In addition to ablation, the nine electrodes can also be used for pacing and sensing.
The small, 9Fr bidirectional catheter enhances maneuverability and access to various anatomical structures and is compatible with a 10Fr sheath, including the custom bidirectional FlexCath Contour™ sheath.
“We are thrilled to see the continuous innovation of our legacy Cryoablation portfolio alongside the approval of the PulseSelect PFA system in the U.S.,” said Khaldoun Tarakji, MD MPH, Chief Medical Officer of the Cardiac Ablation Solutions business at Medtronic. “Every patient deserves the best care. What motivates all of us at Medtronic is the privilege of serving patients by empowering electrophysiologists globally with the safest and most effective ablation technologies that seamlessly integrate with their workflows and enable them to tailor therapy based on their patients’ needs.”The PulseSelect PFA system is also the first FDA Breakthrough-designated PFA technology to be approved. The designation is intended to help patients gain more timely access to medical devices that have the potential to make a significant impact in the diagnosis or treatment of life-threatening conditions.Commercialization of the PulseSelect PFA system will start in early 2024.About Atrial Fibrillation and Pulsed Field AblationAF is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide3. AF is a progressive disease, meaning it can become worse over time and can increase the risk of serious complications including heart failure, stroke and increased risk of death.4-7 Current ablation technologies rely on thermal effects to target cardiac tissue and risk damage to additional collateral structures in the heart. PFA is a breakthrough ablation technology that uses pulsed electric fields to efficiently isolate the pulmonary veins for the treatment of AF. Because the mechanism of cell death is non-thermal, the risk of collateral structure damage is potentially lower. About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com, and follow @Medtronic on LinkedIn.Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Verma A, et al. Circulation. 2023;147:1422-1432
Medtronic data on file. November 2023.
Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126
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