Teleflex enrols first patient in DUBSTENT DIABETES trial www.medicaldevice-network.com Sept. 13, 2025, 3:56 a.m.
This randomised trial will assess a dual-device strategy involving drug-coated balloon (DCB) angioplasty and drug-eluting stent (DES) implantation against single-device approaches using either DCB or DES alone.The study will focus on diabetic patients with de novo coronary artery lesions while addressing a gap in treatment, as these patients often face higher rates of stent failure despite advancements in DES technology.
The path to a hemocompatible cardiovascular implant: Advances and challenges of current endothelialization strategies www.frontiersin.org Sept. 10, 2025, 6:31 a.m.
Technological advances have revolutionized the design, development, and manufacturing of advanced implantable CV devices. However, due to insufficient hemocompatibility, they are still associated with devastating complications. Tissue engineering is an emerging field in contemporary health sciences aimed to optimize CV implants. This scope can be achieved through physical or biochemical surface modification of CV implants aimed to mimicking the physiological endothelial tissue function. The biochemical functionalization described above is difficult from economic and regulatory aspects. Microengineering of CV surface topography can be a promising cost-effective strategy.
New AI Tools Promise Better Tracking & Tracing for Life Sciences www.healthcarepackaging.com Sept. 8, 2025, 9:03 a.m.
TraceLink, the end-to-end digital network platform for intelligent orchestration of the life sciences and healthcare supply chain, has announced significant new platform enhancements to drive supply chain transformation with its Orchestration Platform for Universal Solutions (OPUS). The new capabilities are designed to empower supply chain, finance, commercial, and IT leaders to master today’s supply chain complexities and prepare for the increasing prevalence of goal-oriented AI systems.
DAPT Risk-Benefit Profile Differs Among Patient Populations www.medscape.com Sept. 8, 2025, 8:59 a.m.
Given the growing strength of the evidence that the benefit-to-risk ratio of antiplatelet therapy following myocardial infarction differs markedly by the variables that increase risk for recurrent thrombosis or bleeding, Bhatt believes that risk scoring strategies will be used increasingly. Rather than “eyeballing” risk factors, he called for an objective approach to match patients to an antiplatelet strategy with an optimal projected balance of benefit to risk.
Airiver Medical Receives IDE Approval for Pulmonary Drug Coated Balloon Study medtechintelligence.com Sept. 1, 2025, 12:41 p.m.
Central airway stenosis, otherwise defined as airway narrowing, is often associated with prolonged intubation, tracheostomy, stenting, tuberculosis or lung transplant. There are approximately 100,000 tracheo-bronchial stenting and dilation procedures performed annually within the United States. The study will serve as the basis for Airiver Medical’s regulatory submission to the FDA and eventual commercialization of the Airiver Pulmonary DCB in the U.S.
First patients enrolled in MAGICAL-SV study of sirolimus DCB in small coronary vessels cardiovascularnews.com Aug. 11, 2025, 7:46 a.m.
Concept Medical has announced the enrolment of the first patient in the MAGICAL-SV trial, a US investigational device exemption (IDE) study evaluating its MagicTouch sirolimus-coated balloon (SCB) for the treatment of small coronary vessels, following US Food and Drug Administration (FDA) IDE approval.
Stent-ectasia : Is stent oversizing good or bad ? drsvenkatesan.com Aug. 7, 2025, 9 p.m.
While stent length mismatch is much more common and taken less seriously,diameter mismatch can be more problematic since it looks strikingly odd & ugly .Still, one section of cardiologists believes a little amount of oversizing is safe and good. There is equal opposition to this concept as well. It is not surprising , acquired stent-ectasia of coronary artery during PCI ,has both advantages as well as troubling issues.
Self-adaptive covalent coating for vascular stents: Coordinated coagulation-inflammation regulation to support re-endothelialization for atherosclerosis control  www.sciencedirect.com Aug. 7, 2025, 10:04 a.m.
The self-adaptive anti-coagulant functional modules within the coating was achieved by thrombin-responsive nanogels. By responding to thrombin, the upstream initiator of coagulation-inflammation, the nanogels dynamically regulated anti-coagulant drug delivery, releasing the therapeutic agents in high thrombotic risk conditions while retaining them in low-risk states. To enhance the blockade of coagulation-inflammation loop, the polyphenol epigallocatechin gallate (EGCG) acted as anti-inflammatory functional modules and participated in coating construction as a cross-linking agent.
Angular difference in human coronary artery governs endothelial cell structure and function  www.nature.com Aug. 3, 2025, 10:10 a.m.
Through the detection of biochemical markers, we recorded significant alteration in eNOS, ICAM1, and monocyte attachment in EC grown in microchannel having 60o vessel branching angle which correlated with the lower WSS. The present study highlights the importance of blood vessel branching angle as one of the crucial determining factors in governing atherogenic-endothelial dysfunction.
Integration of substrate- and flow-derived stresses in endothelial cell mechanobiology  www.nature.com Aug. 3, 2025, 10:05 a.m.
Cellular mechanobiology is an active field of research that nicely complements the more traditional biochemically-centered view of most biological processes. As we have highlighted throughout this review, mechanical forces are particularly diverse, dynamic, and multifaceted in the vascular system, and these forces play a critical role in regulating vascular physiology and pathology. In light of the fact that many of these forces are borne most directly by the endothelium, elucidating the mechanisms governing EC mechanobiology will enhance our understanding of the etiology of various vascular diseases including atherosclerosis, thrombosis, aneurysm formation, and diabetes.
Detecting structural heart disease from electrocardiograms using AI www.nature.com July 30, 2025, 9:04 p.m.
The model demonstrated high diagnostic accuracy in internal and external validation, outperforming cardiologists in a controlled evaluation and showing consistent performance across different care settings and racial and/or ethnic groups. The models were prospectively evaluated in a clinical trial of patients without previous cardiac imaging, successfully identifying previously undiagnosed heart disease. These findings support the potential of artificial intelligence to expand access to heart disease screening at scale. To enable further development and transparency, we have publicly released model weights and a large, annotated dataset linking heart rhythm data to imaging-based diagnoses.
Sinomed's HT Supreme Coronary Stent receives conditional PMA approval from US FDA news.10jqka.com.cn July 28, 2025, 9:49 a.m.
This is the first conditional approval of three types of domestic high-end implanted medical devices obtained by the U.S. FDA through the pre-market approval (PMA) path, marking an important milestone in the overseas going of domestic coronary stents.According to the announcement, the product is developed based on the theory of "the existence of a time window for arterial and vascular trauma healing" pioneered by Saino Medical International. Its design goal is different from the traditional stent that only inhibits smooth muscle proliferation, but aims to accelerate the patient's trauma healing and functional recovery of vascular endothelium.
NMPA Approval for Inari FlowTriever Retrieval Aspiration System chinameddevice.com July 22, 2025, 10:07 a.m.
This product is intended for catheter-directed thrombectomy treatment in patients with acute high-risk pulmonary embolism (PE) or intermediate-risk PE with clinical deterioration, under one of the following conditions:The presence of thrombus in the main pulmonary artery or major branches, with a high risk of bleeding or contraindications to thrombolytic therapy;The presence of thrombus in the main pulmonary artery or major branches, and the patient has failed thrombolysis or aggressive medical therapy.
Colchicine in patients with aortic stenosis undergoing transcatheter aortic valve replacement: a double-blind randomized trial  www.nature.com July 21, 2025, 10:05 a.m.
In summary, in patients with severe aortic stenosis undergoing TAVR, treatment with colchicine was associated with a lower risk of new-onset atrial fibrillation or atrioventricular conduction disturbances requiring the implantation of a permanent pacemaker at 30 days. In addition, a pre-specified imaging analysis demonstrated a significant reduction in subclinical leaflet thrombosis in patients treated with colchicine as compared to placebo. The trial was however prematurely halted due to a higher rate of stroke in patients treated with colchicine. Confirmatory trials with colchicine or other inflammatory agents, i.e. monoclonal antibodies targeting interleukin1-β or interleukin-6 are warranted to corroborate the effect of anti-inflammatory treatment on the incidence of arrhythmias and subclinical leaflet thrombosis after TAVR.
A Giant Left Anterior Descending Artery Aneurysm and an Updated Review on Coronary Aneurysms www.ajconline.org July 14, 2025, 10:03 a.m.
Coronary aneurysm is defined as a focal dilation of the coronary artery that is at least 1.5 times the diameter of an adjacent normal segment.1 The term coronary aneurysm is often interchangeably used with coronary ectasia, which is arbitrarily defined as a more diffuse dilation of the coronary artery of the same dimensional features as an aneurysm.2 Coronary aneurysms and ectasia are observed in at least 5% of patients who underwent coronary imaging.3 Given the recent expansive use of noninvasive coronary artery imaging, especially coronary computed tomography angiography and magnetic resonance imaging angiography, the detection of coronary aneurysm has become more frequent.4
Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes  bmcmedicine.biomedcentral.com July 14, 2025, 9:58 a.m.
The first-generation bioresorbable scaffolds (BRS) have been associated with higher rates of device-related adverse outcomes in comparison to everolimus-eluting stents. We aimed to evaluate the efficacy and safety of the thinner-strut (100/125 μm) poly-L-lactic acid-based sirolimus-eluting Firesorb BRS in patients with de novo coronary lesions.
Teleflex completes acquisition of Biotronik’s Vascular Intervention business cardiovascularnews.com July 7, 2025, 2:29 p.m.
The acquired Vascular Intervention business consists of a portfolio for coronary and peripheral interventions performed in the cath lab and interventional radiology suites. In coronary vascular interventions, Teleflex details that key products include the Pantera Lux drug-coated balloon catheter, the novel PK Papyrus covered coronary stent for acute coronary artery perforations, and the Orsiro Mission drug-eluting stent, an ultrathin drug-eluting stent with differentiated clinical features. For peripheral interventions, the portfolio includes the Passeo-18 Lux peripheral drug-coated balloon catheter, Dynetic-35 balloon-expandable cobalt chromium stent, the Pulsar-18 T3 self-expanding 4F stent, and the Oscar peripheral multifunctional catheter system.
Cumulative Plaque Burden index for determining the diffuseness of atherosclerotic coronary artery disease www.internationaljournalofcardiology.com June 30, 2025, 5:31 p.m.
In this study, we propose CPBi, a novel AI-powered IVUS-derived metric, to objectively quantify the diffuseness of atherosclerotic coronary artery disease (ACAD) across the entire vessel. This approach provides insight into the distribution of atherosclerosis without requiring hyperemic pressure wire pullback and supports clinical decision-making for optimal stent strategy.
Leukocyte-shed soluble CD31 unmasks coronary disease in low-risk outliers and provides source-specific inflammatory signatures of vulnerable plaques www.atherosclerosis-journal.com June 28, 2025, 10:27 a.m.
Leukocyte-shed sCD31 unmasks coronary disease in low-risk outliers and provides source-specific inflammatory signatures of vulnerable plaques. The differential pattern of sCD31 forms based on risk burden suggests distinct pathophysiological mechanisms driving atherosclerosis in different patient populations, addressing a critical gap in current risk assessment.