Stent

According to THE SAGE GROUP, High Restenosis Rates Following Endovascular Treatment of Infrapopliteal Disease Create a Significant Need for Improved Technologies

Retrieved on: 
Thursday, February 16, 2023
Science, Research, Health, Diabetes, Consulting, Medical Devices, Health Technology, Professional Services, DCB, Orchestra, Restenosis, TLR, MED, SLR, Patient, Incidence, Magic Touch, Stent, SAGE, SCB, DES, PCB, Safety, PAD, FDA, Sundance, Paclitaxel, Pharmaceutical industry

Recent research published by THE SAGE GROUP examines the challenges of infrapopliteal Peripheral Artery Disease (PAD) and incidence of restenosis.

Key Points: 
  • Recent research published by THE SAGE GROUP examines the challenges of infrapopliteal Peripheral Artery Disease (PAD) and incidence of restenosis.
  • “It is difficult to reach strong conclusions regarding device superiority for endovascular treatment of infrapopliteal disease,” stated Mary L. Yost, President of THE SAGE GROUP.
  • In addition to lesion length, these include primary efficacy end points, patient characteristics, lesion characteristics and morphology, as well as disease severity.
  • “In infrapopliteal disease, we believe that new, more effective endovascular devices are needed to reduce restenosis and improve patient outcomes.

MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter

Retrieved on: 
Monday, February 13, 2023
DCB, Assistant, SR, Regulatory affairs, Quality assurance, PMA, Trireme, The Chocolate Touch, Chocolate, Patient, Stent, Clinical trial, Food, Senior, MCRA, PAD, Moyamoya disease, FDA, PTA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LG Chocolate Touch (VX8575), Peripheral artery disease, Medical device, Pharmaceutical industry, Computer security

This innovative paclitaxel coated PTA balloon catheter, developed by TriReme Medical, LLC, treats patients with peripheral arterial disease (PAD) of the superficial femoral and popliteal arteries.

Key Points: 
  • This innovative paclitaxel coated PTA balloon catheter, developed by TriReme Medical, LLC, treats patients with peripheral arterial disease (PAD) of the superficial femoral and popliteal arteries.
  • MCRA's expert regulatory affairs and quality assurance teams worked closely with TriReme Medical to achieve this significant milestone.
  • Glenn Stiegman, Senior Vice President of Clinical and Regulatory Affairs at MCRA, said "MCRA set out in 2019 to build the industry leading cardiovascular medical device consulting firm.
  • Today, this is evidenced by the successful outcome the MCRA team has helped TriReme Medical achieve.

Concept Medical granted Investigational Device Exemption (IDE) approval for their Magic Touch Sirolimus Coated Balloon for the treatment of Below the Knee (BTK) Arterial Disease

Retrieved on: 
Monday, February 13, 2023
Sirolimus, CE, Physician, CMI, Artery, III, Gold, PMA, Safety, Coronary, Columbia University, Patient, Hospital, Magic Touch, Stent, Investigational device exemption, Clinical trial, IDE, Columbia University Irving Medical Center, Debate, RCT, Paclitaxel, Sengkang General Hospital, PAD, OUS, Sengkang, BTK, Isabella Tree, Medical device, Pharmaceutical industry, Moyamoya disease, POBA

TAMPA, Fla., Feb. 13, 2023 /PRNewswire/ -- Concept Medical Inc. (CMI), on 9thFebruary 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon.

Key Points: 
  • TAMPA, Fla., Feb. 13, 2023 /PRNewswire/ -- Concept Medical Inc. (CMI), on 9thFebruary 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon.
  • The Magic Touch PTA Sirolimus Coated Balloon Catheter is indicated for the treatment of Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Disease.
  • CMI received their first IDE approval for their Magic Touch Sirolimus Coated Balloon for the Coronary ISR indication earlier in September 2022.
  • The Magic Touch PTA Sirolimus Coated Balloon Catheter has also been granted with a breakthrough device designation in BTK by the US FDA.

Concept Medical granted Investigational Device Exemption (IDE) approval for their Magic Touch Sirolimus Coated Balloon for the treatment of Below the Knee (BTK) Arterial Disease

Retrieved on: 
Monday, February 13, 2023
Sirolimus, CE, Physician, CMI, Artery, III, Gold, PMA, Safety, Coronary, Columbia University, Patient, Hospital, Magic Touch, Stent, Investigational device exemption, Clinical trial, IDE, Columbia University Irving Medical Center, Debate, RCT, Paclitaxel, Sengkang General Hospital, PAD, OUS, Sengkang, BTK, Isabella Tree, Medical device, Pharmaceutical industry, Moyamoya disease, POBA

TAMPA, Fla., Feb. 13, 2023 /PRNewswire/ -- Concept Medical Inc. (CMI), on 9thFebruary 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon.

Key Points: 
  • TAMPA, Fla., Feb. 13, 2023 /PRNewswire/ -- Concept Medical Inc. (CMI), on 9thFebruary 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon.
  • The Magic Touch PTA Sirolimus Coated Balloon Catheter is indicated for the treatment of Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Disease.
  • CMI received their first IDE approval for their Magic Touch Sirolimus Coated Balloon for the Coronary ISR indication earlier in September 2022.
  • The Magic Touch PTA Sirolimus Coated Balloon Catheter has also been granted with a breakthrough device designation in BTK by the US FDA.

Atherosclerosis, Vascular Injury, and the Hunt for Drug Targets: Pusan National University and Korean Researchers' New Findings

Retrieved on: 
Friday, February 3, 2023
Membrane protein, VSMC, Artery, Neointima, Biology, NIH, Cardiac arrest, Canadian International Council, Stent, GSE, Research, Stenosis, Protein kinase B, Cell proliferation, Death, Stroke, Gene, Gene Expression Omnibus, PCK2, International Journal of Biological Sciences, Disease, Dick's Picks Volume 18, Pusan National University, Pharmaceutical industry, Medical imaging, Vaccine, Atherosclerosis

And for better therapies, we need a better understanding of the process that leads to NIH, VSMC proliferation, and vascular injury.

Key Points: 
  • And for better therapies, we need a better understanding of the process that leads to NIH, VSMC proliferation, and vascular injury.
  • A group of researchers from Korea, led by Professor Yun Hak Kim of Pusan National University, set out to find answers.
  • It is via these pathways that PCK2 and its gene regulate VSMC proliferation after vascular injury, the team reported.
  • And given the findings of our study, we believe this enzyme can also be targeted to prevent arterial re-stenosis after stent placement and improve outcomes of vascular injury treatment."

Glaucoma Surgery Devices Market Report to 2029 - Featuring Abbott Medical Optics, Topcon, Lumenis and Allergan Among Others - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 17, 2023
Optical, Health, Surgery, Medical Devices, Ahmad, Central New York Regional Market, Stent, Hospital, Growth, Drainage, Surgeon, Prevalence, Eye disease, Risk, Glaucoma, Knowledge, Health insurance

In terms of surgery type, the market is divided into conventional glaucoma surgeries and minimally invasive glaucoma surgeries.

Key Points: 
  • In terms of surgery type, the market is divided into conventional glaucoma surgeries and minimally invasive glaucoma surgeries.
  • In 2021, the glaucoma drainage devices accounted for the highest revenue share due to increase in acceptance of drainage devices like Ahmed valves or aqueous shunts over traditional glaucoma procedures.
  • On the basis of end user, the market is categorized into ophthalmic clinic, hospitals, and ambulatory surgical centres.
  • Regional Markets In 2021, North America region accounted for the highest revenue in the glaucoma surgery devices market and is expected to maintain its dominance during the forecast period.

Cardiovascular Systems, Inc. Enrolls First Patient in Japan for Kaizen Clinical Study

Retrieved on: 
Wednesday, January 11, 2023
Medical Devices, Other Health, Health, Clinical Trials, Cardiology, De novo, OAS, Trial of the century, Interventional cardiology, Diamondback, Safety, Coronary artery disease, Stent, Plaque, Patient, Artery, Atherosclerosis, CSI, Popliteal artery, KAIZEN, PAD, Physician, Peripheral artery disease, Pharmaceutical industry, Medical device, Medical imaging

The first KAIZEN patient was enrolled by Tatsuya Nakama, M.D., Vice Director, Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center.

Key Points: 
  • The first KAIZEN patient was enrolled by Tatsuya Nakama, M.D., Vice Director, Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center.
  • Dr. Nakama said, “I felt that the Diamondback 360© Peripheral OAS offered both effective treatment and ease of use.
  • OAS has demonstrated safety and efficacy in the U.S. population and this study is designed to confirm this in Japan.
  • I believe the Diamondback 360© Peripheral OAS has great potential for this underserved patient population, and I look forward to evaluating it in Japan.

Endologix Receives FDA Approval of PMA Supplement for AFX2 System

Retrieved on: 
Wednesday, December 7, 2022
Medical Devices, FDA, Health, Health Technology, Cardiology, Biotechnology, AAA, AFX, Food, EVAR, Medical journal, Sale, Randomized controlled trial, The BMJ, FDA, Vascular disease, Stent, Multimedia, PMA, Use, Food and Drug Administration, Mortality, Rupture, Aortic aneurysm, Acquisition, Pharmaceutical industry

Endologix LLC, a privately held global medical device company, dedicated to improving patients lives with innovative interventional treatments for vascular disease, today announced that it has received U.S. Food and Drug Administration (FDA) approval for a pre-market approval (PMA) supplement relating to the AFX2 System.

Key Points: 
  • Endologix LLC, a privately held global medical device company, dedicated to improving patients lives with innovative interventional treatments for vascular disease, today announced that it has received U.S. Food and Drug Administration (FDA) approval for a pre-market approval (PMA) supplement relating to the AFX2 System.
  • View the full release here: https://www.businesswire.com/news/home/20221207005348/en/
    Endologix received approval to include an updated warning and the most contemporary clinical information in the labeling for the AFX2 System.
  • Endologixs current commercial EVAR products include the AFX2 Endovascular AAA System and the ALTO Abdominal Stent Graft System.
  • The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body.

Endologix Announces 12-Month Results of DETOUR-2 Trial at 2022 VIVA Late-Breaking Clinical Trial Session

Retrieved on: 
Friday, November 11, 2022
Health, Clinical Trials, Medical Devices, Amputation, CEO, Clinical trial, Sale, FDA, PBRC, Arnold, Cleveland, Calcification, DVT, Stent, Technology, EVAR, Death, PMA, MAE, Stenosis, PTAB, Advanced cardiac life support, Acquisition, IDE, Patient, Freedom, Quality of life, FACC, Safety, Forward-looking statement, Aortic aneurysm, VIVA, Conference, Vascular disease, Population, Department, Pulmonary embolism, First Ever, Medical imaging, Medical device, Health insurance, Pharmaceutical industry

The DETOUR 2 clinical trial has enrolled 202 patients in the United States and Europe for the primary analyses.

Key Points: 
  • The DETOUR 2 clinical trial has enrolled 202 patients in the United States and Europe for the primary analyses.
  • A Pre-Market Approval (PMA) Application for the DETOUR Systems was submitted to the FDA in October 2022.
  • The results presented are listed below:
    Ninety-six percent of enrolled patients had chronic total occlusions, with a mean lesion length of 32.7cm.
  • The 1-year effectiveness endpoint was also met, with 72.1% freedom from CD-TLR and recurrent stenosis > 50% at 12 months.

Coronary Stent Co-Inventor and Gene Therapy Pioneer, Dr. Richard Schatz, Joins GATC Health as Chairman of its Medical Advisory Board

Retrieved on: 
Thursday, November 10, 2022
National Academy of Inventors, Alumnus, American College of Cardiology, Duke University Hospital, Coronary circulation, Duke University, Health, Invention, Intelligence, Brooke Army Medical Center, Coronary artery disease, Buffalo buffalo Buffalo buffalo buffalo buffalo Buffalo buffalo, MAT, Biology, Risk, Angioplasty, National academy, Technology, State university system, Population, Lung, Drug discovery, Artificial intelligence, Multimedia, Disease, Degenerative disease, Mortality, GATC, Efficiency, Duke University School of Medicine, Nobel Prize, Precision medicine, Medicine, Buffalo, Company, Science, Biological engineering, Moyamoya disease, University, Patient, Heart, Therapy, Stent, University of Texas Health Science Center at San Antonio, MD, FDA, Restenosis, American College, Medical device, Pharmaceutical industry, Cardiology

Dr. Schatz, a recognized international expert in interventional cardiology and co-inventor of the coronary stent, will propel GATC Health's development of novel therapeutics, diagnostics and genomic risk reports related to heart disease.

Key Points: 
  • Dr. Schatz, a recognized international expert in interventional cardiology and co-inventor of the coronary stent, will propel GATC Health's development of novel therapeutics, diagnostics and genomic risk reports related to heart disease.
  • "Dr Schatz leading our Medical Advisory Board as Chairman is a major endorsement of the value of our platform and its potential to support heart health," said Jeff Moses, President of GATC Health.
  • He was honored with both the distinguished alumnus award and the Lifetime Scholar Award by Duke University Medical Center.
  • GATC envisions the future of medicine now, where health is protected, disease is reversed and every person's unique biology is treated with precision.