Restenosis

Orchestra BioMed Demonstrates Strength of Cardiovascular Pipeline with Virtue® SAB and AVIM Therapy Presentations at CRT 2024 Annual Meeting

Retrieved on: 
Wednesday, March 13, 2024
Blood pressure, CRT, Investigational device exemption, HOPE, Patient, Inflammation, Stroke, Gold, Restenosis, ISR, Medtronic, Beat (music), Trial of the century, Virtue, Sirolimus, Stent, Safety, Pharmacokinetics, SAB, Hypertension, Molecular mass, Food, Medical device

A second presentation featured recently reported clinical data on atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT), an investigational therapy delivered via standard dual-chamber pacemakers designed to immediately, substantially and persistently lower blood pressure.

Key Points: 
  • A second presentation featured recently reported clinical data on atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT), an investigational therapy delivered via standard dual-chamber pacemakers designed to immediately, substantially and persistently lower blood pressure.
  • The AVIM presentation also outlined the design of the currently enrolling BACKBEAT global pivotal study evaluating AVIM therapy in hypertensive pacemaker patients in collaboration with Medtronic.
  • Specifically, the presented PK data showed that:
    Molecular weight of Sostenocel remained unchanged prior to elimination, showing no evidence of in-vivo degradation.
  • AVIM therapy demonstrated:
    Consistent favorable hemodynamic effects using both conduction system, as well as traditional right ventricular lead placements.

Global Balloon Catheter Market Analysis Report 2023-2030: Minimally Invasive Solutions and Age-Associated Cardiovascular Problems Drive Demand - ResearchAndMarkets.com

Retrieved on: 
Friday, March 22, 2024
Medical Supplies, Medical Devices, Health, Surgery, Cardiology, Biotechnology, Coronary artery disease, Balloon catheter, Neurology, Prevalence, Headache, Urbanization, Blood, Peripheral artery disease, Urology, Angioplasty, Nylon, Hospital, Restenosis, Research, Splenic infarction, Telehealth, Heart, Stroke, Artery, Safety, Prognosis, Catheter, FDA, Artificial intelligence, CAD, Ageing, Medical device

The "Global Balloon Catheter Market, Size, Forecast 2024-2030, Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Balloon Catheter Market, Size, Forecast 2024-2030, Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering.
  • The growing prevalence of age-associated cardiovascular problems propels balloon catheter demand, significantly increasing the medical device market and enhancing the care of growing older populations globally.
  • Offering minimally invasive alternatives to conventional surgeries, balloon catheters lead to faster recuperation instances, decreased dangers, and progressed patient effects, driving market increase towards minimally invasive tactics.
  • By product type, the Global Balloon Catheter Market is divided into Normal Balloon Catheter, Drug Eluting Balloon Catheter, Cutting Balloon Catheter, Scoring Balloon Catheter, Stent Graft Balloon Catheter, and Others.

PECA Labs Receives Expanded CE Mark for exGraft Family of Vascular Grafts, Allowing for Expandability Designed to Match Growth or Help Avoid Restenosis

Retrieved on: 
Tuesday, March 19, 2024
General Health, Consumer, Medical Devices, Hospitals, Health Technology, Children, Surgery, Baby, Maternity, Cardiology, Biotechnology, FDA, Health, Member, X-ray, Growth, Ethics, Patient, Anatomy, Risk, Restenosis, Delaware Valley, University, PECA, Surgeon, Medtech, Ernst & Young, Pediatrics, Hospital, Traction, PwC, Regulation

The exGraft is a synthetic vascular graft built on PECA Labs’ proprietary polymer processing platform that can be permanently expanded.

Key Points: 
  • The exGraft is a synthetic vascular graft built on PECA Labs’ proprietary polymer processing platform that can be permanently expanded.
  • Post-operative expansion is designed to allow for increasing graft diameter, which may enable the graft to match growth in pediatric populations or help to avoid restenosis (narrowing) in adults.
  • The exGraft’s capability to be balloon-expanded in the cath lab provides cardiac care teams greater flexibility in treating patients.
  • “This CE Mark clearance, which results in an expanded label within the exGraft family of vascular grafts, is extremely significant.

Boston Scientific Receives FDA Approval for the AGENT™ Drug-Coated Balloon

Retrieved on: 
Friday, March 1, 2024
Boston Scientific, Diabetes, Obstruction, DCB, Interventional cardiology, Physician, FDA, ISR, Quality of life, Food, Restenosis, Find, BSX, IDE, Plaque, Radiation, Risk, Food and Drug Administration, Patient, TLF, Coronary artery disease, Pharmaceutical industry

MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue.

Key Points: 
  • First coronary drug-coated balloon in U.S. provides safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence
    MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.
  • ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue.
  • Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9029352-boston-scientific-fda-ap...
    "With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the U.S," said Lance Bates, president, Interventional Cardiology Therapies, Boston Scientific.
  • Boston Scientific plans to launch the technology in the U.S. in the coming months.

Global Drug Eluting Stent Market Size, Share & Trends Analysis Report 2023-2030 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 12, 2023
Medical Devices, Health, Restenosis, Safety, Prevalence, CVD, Application, Peripheral artery disease, Patient, Death, Obesity, USD, COVID-19, Coronary artery disease, Ageing, Risk, DES, Diabetes, Stent, Pharmaceutical industry

The "Drug Eluting Stent Market Size, Share & Trends Analysis Report By Coating Type (Polymer-based Coatings (Non-biodegradable, Biodegradable)), Polymer-free Coatings, By Application, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Drug Eluting Stent Market Size, Share & Trends Analysis Report By Coating Type (Polymer-based Coatings (Non-biodegradable, Biodegradable)), Polymer-free Coatings, By Application, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global drug eluting stent market size is expected to reach USD 13.65 billion by 2030, advancing at a CAGR of 8.4%
    An aging population and the increasing prevalence of risk factors such as cardiovascular diseases (CVDs), complex lesions, diabetes, obesity, and others are expected to drive the demand for drug eluting stents over the forecast period.
  • Additionally, ongoing technological advancements in stent design, including improvements in coatings and drug delivery mechanisms, are enhancing the safety and efficacy of these devices, making them more appealing to patients and healthcare professionals.
  • The market for drug eluting stents was significantly impacted by the COVID-19 pandemic, with disruptions in the supply chain of medical devices.

Kaneka Acquires Japan Medical Device Technology

Retrieved on: 
Wednesday, December 6, 2023
Surgery, Medical Devices, Health, Cardiology, Medical Supplies, Atherosclerosis, Human body, Restenosis, Kaneka, Research, Biliary tract, Artery, Extremities, Esophagus, Metal, Sirolimus, Coronary artery disease, Risk, Corporation, Multimedia, FIH, Duodenum, Thrombosis, Blood, Human, Trachea, Kaneka Corporation, Pharmaceutical industry

Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Minoru Tanaka)(TOKYO:4118) has acquired all shares of Japan Medical Device Technology Co., Ltd. (Headquarters: Kamimashiki-gun, Kumamoto; President: Shuzo Yamashita) (hereinafter JMDT), a developer and manufacturer of medical devices, on November 30, 2023, and made it a wholly owned subsidiary.

Key Points: 
  • Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Minoru Tanaka)(TOKYO:4118) has acquired all shares of Japan Medical Device Technology Co., Ltd. (Headquarters: Kamimashiki-gun, Kumamoto; President: Shuzo Yamashita) (hereinafter JMDT), a developer and manufacturer of medical devices, on November 30, 2023, and made it a wholly owned subsidiary.
  • In particular, stenting*1 for the treatment of coronary artery diseases such as atherosclerosis has a market worth 30 billion yen in Japan, and Kaneka is aiming to expand its business in this area.
  • It is a medical device that widens tubular parts of the human body (blood vessels, trachea, esophagus, duodenum, colon, biliary tract, etc.)
  • [Japan Medical Device Technology Co., Ltd.]

Surmodics Announces SWING Trial 24-Month Data to be Presented at VEITH Symposium on November 15

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Medical Devices, Health, Clinical Trials, Medical Supplies, Sale, Aortoiliac occlusive disease, DCB, Cell, Sundance, ISET, Master of Medicine, Freedom, Restenosis, Safety, PHD, Ambient occlusion, PP, MS, Pharmaceutical industry, MBBS, Anesthetic, FRACS

The session will be held on Wednesday, November 15th, at the 50th annual VEITH Symposium in New York, New York.

Key Points: 
  • The session will be held on Wednesday, November 15th, at the 50th annual VEITH Symposium in New York, New York.
  • Professor Varcoe previously presented SWING Trial 12-month data on January 18th at the 35th Annual International Symposium on Endovascular Therapy (ISET) conference.
  • Sirolimus, a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents.
  • The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.

Occlusion Perfusion Catheter Demonstrates Superior Performance in PAD Drug Delivery

Retrieved on: 
Thursday, November 2, 2023
ACT, Frontiers in Cardiovascular Medicine, Peripheral artery disease, De novo, Sirolimus, Paclitaxel, Cardiology, Pressure, Disease, Complete circumferential peripheral and deep margin assessment, Restenosis, OPC, Safety, BTK, Stent, PAD, Medical device, Pharmaceutical industry

CHATTANOOGA, Tenn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- The Occlusion Perfusion Catheter (OPC), a multi-lumen balloon catheter from Advanced Catheter Therapies (ACT), was recently selected by researchers for use in exploring a new treatment approach for peripheral artery disease (PAD) and restenosis.

Key Points: 
  • CHATTANOOGA, Tenn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- The Occlusion Perfusion Catheter (OPC), a multi-lumen balloon catheter from Advanced Catheter Therapies (ACT), was recently selected by researchers for use in exploring a new treatment approach for peripheral artery disease (PAD) and restenosis.
  • Sirolimus is currently being explored as an alternative drug to paclitaxel for the treatment of PAD.
  • To date, sirolimus has only been used as drug coatings for stents and balloons and no studies have yet demonstrated the delivery of sirolimus in liquid form.
  • “ Pre-clinical investigation of liquid sirolimus for local drug delivery ” was published September 15, 2023, in Frontiers in Cardiovascular Medicine .

First Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Tuesday, October 31, 2023
Atheroma, Peripheral artery disease, Diabetes, Pivotal trial, Ulcer, Transducer, Male, Disease, PAP, Buerger's test, Classification, The Unreconstructed M, IVUS, Amputation, Stent, PAD, PP, Thorpe tube flowmeter, TUS, Calf, Chin Na, Vein, Telephone, TASC, Bare, Vibrato, Life, SP, W. L. Gore & Associates, VIVA, Safety, Patient, Dyslipidemia, Blood vessel, Plaque, History, CLTI, Coronary artery disease, Perfusion, Restenosis, Research, Foot, Spur, Atherectomy, Șaeș, Artery, Education, DCB, Doppler effect, Dialysis, Hypertension, FP, Freedom, Wynn Las Vegas, Wound healing, Medical imaging, Pharmaceutical industry, Birth control, Surveying, Medtronic

Below are highlights of this morning's 5 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this morning's 5 late-breaking clinical trial presentations.
  • At 20 centers without roll-ins across the United States, 105 no-option CLTI patients were enrolled in a nonrandomized manner.
  • The median age was 70 years, two-thirds of the patients were male, and one-quarter of patients were Hispanic or Latino.
  • 1-Year Results of the DEEPER OUS Trial: The Bare Temporary Spur Stent System in Combination With a Paclitaxel-Coated Balloon
    The DEEPER OUS trial is a prospective, nonrandomized, multicenter, single-arm trial taking place in New Zealand, Germany, and Switzerland.

Advanced NanoTherapies (ANT) Secures $4M Strategic Investment to Accelerate Clinical Development of SirPlux Duo Drug-Coated Balloon (DCB) for Treating de novo Coronary Artery Disease (CAD)

Retrieved on: 
Tuesday, August 22, 2023
Auckland City Hospital, Cleveland Clinic, Cleveland Clinic Akron General, Structural heart disease, Restenosis, CAD, Paclitaxel, Doctor of Philosophy, De novo, DCB, Sirolimus, Interventional cardiology, MD, Patient, DCB Bank, Vascular disease, ANT, Education minister, FIH, Entrepreneurship, LOS, Coronary artery disease, Nanotechnology, Safety, Pharmaceutical industry

LOS GATOS, Calif., Aug. 22, 2023 /PRNewswire/ -- Advanced NanoTherapies Inc. (ANT), a clinical-stage medical device company committed to solving the most significant challenges in vascular disease through the creative applications of nanotechnology, today announced a $4M Series A extension from a prominent undisclosed strategic medical device company. Additionally, ANT successfully treated the first cohort of study participants in its ADVANCE-DCB first-in-human (FIH) trial, demonstrating initial short-term safety data for the next-generation SirPlux Duo Drug-Coated Balloon (DCB). The trial is evaluating the safety and performance of the SirPlux Duo DCB in de novo coronary artery disease (CAD).

Key Points: 
  • Additionally, ANT successfully treated the first cohort of study participants in its ADVANCE-DCB first-in-human (FIH) trial, demonstrating initial short-term safety data for the next-generation SirPlux Duo Drug-Coated Balloon (DCB).
  • The trial is evaluating the safety and performance of the SirPlux Duo DCB in de novo coronary artery disease (CAD).
  • "Today, we celebrate two remarkable accomplishments for ANT and SirPlux Duo DCB," said Marwan Berrada, Co-Founder and CEO of ANT.
  • "I welcome the participation of a new strategic partner as this additional investment will bolster ANT's clinical programs and accelerate the path toward U.S. IDE approval for the SirPlux Duo DCB.