Restenosis

Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease

Retrieved on: 
Monday, May 1, 2023
Stent, Small Vessel, Investigational device exemption, Cardiac muscle, PTA, Restenosis, CAD, ISR, Revascularization, MACE, Trial of the century, PCI, Microangiopathy, Sirolimus, PMA, Patient, Physician, Risk, IDE, Coronary artery disease, FDA, SCB, Cutaneous small-vessel vasculitis, Drug-eluting stent, US FDA, Safety, Pharmaceutical industry, MD, TITAN

TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.

Key Points: 
  • TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.
  • US FDA, on the 25th of April 2023, granted the third IDE approval for Concept Medical's Sirolimus Coated Balloon – MagicTouch SCB.
  • Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA).
  • The current IDE approval will allow Concept Medical to initiate pivotal clinical study to support safety and effectiveness of the MagicTouch SCB in small vessel coronary disease.

Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease

Retrieved on: 
Monday, May 1, 2023
Stent, Small Vessel, Investigational device exemption, Cardiac muscle, PTA, Restenosis, CAD, ISR, Revascularization, MACE, Trial of the century, PCI, Microangiopathy, Sirolimus, PMA, Patient, Physician, Risk, IDE, Coronary artery disease, FDA, SCB, Cutaneous small-vessel vasculitis, Drug-eluting stent, US FDA, Safety, Pharmaceutical industry, MD, TITAN

TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.

Key Points: 
  • TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.
  • US FDA, on the 25th of April 2023, granted the third IDE approval for Concept Medical's Sirolimus Coated Balloon – MagicTouch SCB.
  • Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA).
  • The current IDE approval will allow Concept Medical to initiate pivotal clinical study to support safety and effectiveness of the MagicTouch SCB in small vessel coronary disease.

Olympus to Acquire Korean Gastrointestinal Stent Company Taewoong Medical Co., Ltd

Retrieved on: 
Friday, February 24, 2023
Stenosis, Cancer, Colon, Endoscopy, Anatomy, Jaundice, Ageing, Duodenum, Acquisition, Risk, Gastrointestinal disease, Standard of care, Global Burden of Disease Study, Stent, Patient, Mechanical, Investment, MM, Esophagus, Self-expandable metallic stent, Gallbladder, Restenosis, Cholangiocarcinoma, Biliary tract, JPY, International, Sale, Metallic, Bile, Disease, Olympus, Pharmaceutical industry, Medical imaging, Fine chemical, Software, GI

Taewoong Medical, a leading manufacturer of GI stents, offers a variety of medical devices including metallic stents designed for biliary tract, esophagus, colon, and duodenum treatments[5].

Key Points: 
  • Taewoong Medical, a leading manufacturer of GI stents, offers a variety of medical devices including metallic stents designed for biliary tract, esophagus, colon, and duodenum treatments[5].
  • "Taewoong Medical has developed a full portfolio of GI metal stents that will immediately enhance our already robust offering of GI devices.
  • Kyong-min Shin, President and CEO of Taewoong Medical stated, "For over three decades, Taewoong Medical has been a leading manufacturer of GI stents, renowned for its innovative technology and diverse product range.
  • Moving forward together with Olympus, Taewoong Medical will focus its capabilities to provide medical professionals and patients with superior products and services through continuous investment in R&D and manufacturing technology."

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.

Asia Pacific Vascular Patches Market Report 2022: Featuring Edwards Lifesciences, Baxter International, Lemaitre Vascular, Becton, Dickinson & More - ResearchAndMarkets.com

Retrieved on: 
Friday, January 27, 2023
Medical Supplies, Health, Congenital heart defect, Superior, Restenosis, Stroke, Country, Synthetic, Carotid artery stenosis, Splenic infarction, Patient, Incidence, Abdominal aortic aneurysm, Fatality, Application, Radiation exposure, Biologic, Atherosclerosis, Cardiovascular disease, Hospital, Peripheral artery disease, Medical device, Pharmaceutical industry

The development of vascular surgery techniques and the treatment of vascular diseases will be influenced by impending technological developments.

Key Points: 
  • The development of vascular surgery techniques and the treatment of vascular diseases will be influenced by impending technological developments.
  • Statin medications are just becoming widely available, yet their use has already decreased the number of strokes, heart attacks, and fatalities.
  • The China market dominated the Asia Pacific Vascular Patches Market by Country in 2021, and would continue to be a dominant market till 2028; thereby, achieving a market value of $41, 515.5 Thousands by 2028.
  • Based on countries, the market is segmented into China, Japan, India, South Korea, Singapore, Malaysia, and Rest of Asia Pacific.

Asia Pacific Vascular Patches Market Report 2022: Sector to Grow by 7.9% Annually Through 2028

Retrieved on: 
Monday, January 30, 2023
Incidence, Peripheral artery disease, Carotid artery stenosis, Superior, Cardiovascular disease, Fatality, Country, Atherosclerosis, Splenic infarction, Restenosis, Synthetic, Application, Congenital heart defect, Abdominal aortic aneurysm, Stroke, Biologic, Hospital, Patient, Radiation exposure, Medical device, Pharmaceutical industry

The development of vascular surgery techniques and the treatment of vascular diseases will be influenced by impending technological developments.

Key Points: 
  • The development of vascular surgery techniques and the treatment of vascular diseases will be influenced by impending technological developments.
  • Statin medications are just becoming widely available, yet their use has already decreased the number of strokes, heart attacks, and fatalities.
  • The China market dominated the Asia Pacific Vascular Patches Market by Country in 2021, and would continue to be a dominant market till 2028; thereby, achieving a market value of $41, 515.5 Thousands by 2028.
  • Based on countries, the market is segmented into China, Japan, India, South Korea, Singapore, Malaysia, and Rest of Asia Pacific.

Surmodics Announces SWING Trial 12-Month Data to be Presented at ISET Conference on January 18

Retrieved on: 
Monday, January 16, 2023
Medical Supplies, Health, Medical Devices, Surgery, Clinical Trials, Pharmaceutical, Cardiology, FRANZCR, Cell, MS, Auckland City Hospital, Aortoiliac occlusive disease, Safety, SCB Park Plaza, ISET, PHD, ONZM, Master of Medicine, Sale, DCB, Restenosis, International Symposium on Endovascular Therapy, Pharmaceutical industry, FRACS, Bachelor of Medicine, Bachelor of Surgery, MBBS, Anesthetic

The session will be held on Wednesday, January 18, at the 35th annual International Symposium on Endovascular Therapy (ISET) conference in Miami, Florida.

Key Points: 
  • The session will be held on Wednesday, January 18, at the 35th annual International Symposium on Endovascular Therapy (ISET) conference in Miami, Florida.
  • Professor Varcoe will also discuss the differentiated capabilities of the Surmodics crystalline drug release platform for sirolimus-coated balloons (SCBs) in connection with 12-month data from the SWING trial.
  • Professor Varcoe recently presented SWING Trial 12-month data on Nov. 16 at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium).
  • The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.

VentureMed announces First patient Enrolled in the FLEX First AV Registry For The Treatment of Arteriovenous (AV) Access Management

Retrieved on: 
Thursday, December 15, 2022
Medicine, Food, Female, MD, Patient, PTA, ISR, Restenosis, US Foods, AV, Kidney, Moyamoya disease, PAD, CE marking, Medical director, AVF, DCB, FLEX, Pharmaceutical industry

The first patient treated was part of VentureMed's second AV Registry.

Key Points: 
  • The first patient treated was part of VentureMed's second AV Registry.
  • We are excited about utilizing the FLEX Vessel Prep System in hopes that it will extend our patients access patency allowing them more time between interventions."
  • The FLEX Vessel Prep System has a unique non-balloon-based mechanism of action that creates longitudinal micro-incisions releasing circumferential tension in diseased vessels.
  • The FLEX VP System received CE Mark and 510(k) clearance from the US Food and Drug Administration.

Surmodics Announces 12-Month Data from the SWING Trial Presented at VEITHsymposium

Retrieved on: 
Thursday, November 17, 2022
Medical Supplies, Health, Medical Devices, Surgery, Clinical Trials, Pharmaceutical, Cardiology, MALE, Restenosis, Sale, Ambient occlusion, Peripheral artery disease, Cell, DCB, Freedom, PHD, PP, FRANZCR, MS, Safety, HIV disease progression rates, IVD, Disease, Master of Medicine, Annual report, ONZM, Growth, Classification, MD, Aortoiliac occlusive disease, Pharmaceutical industry, Medical imaging, FRACS, MBBS, Bachelor of Medicine, Bachelor of Surgery

The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography.

Key Points: 
  • The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography.
  • Both primary endpoints of the SWING Trial were achieved.
  • Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects.
  • The SWING Trial demonstrates that the Sundance Sirolimus DCB has tremendous promise and warrants evaluation in a large-scale pivotal trial.

Surmodics Announces SWING Trial 12-Month Data to be Presented at VEITHsymposium on November 16

Retrieved on: 
Friday, November 11, 2022
Medical Devices, Health, Surgery, Clinical Trials, General Health, Pharmaceutical, Aortoiliac occlusive disease, Sale, Company, Annual report, NASDAQ, Disease, Auckland City Hospital, Technology, Cell, DCB, SEC, Safety, Investor, 3rd Floor, Forward-looking statement, MS, Restenosis, Master of Medicine, FRANZCR, AMP, Growth, Amputation, PHD, ONZM, Pharmaceutical industry, Bachelor of Medicine, Bachelor of Surgery, FRACS, Anesthetic, MBBS

The session will be held on Wednesday, November 16, at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium) in New York City.

Key Points: 
  • The session will be held on Wednesday, November 16, at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium) in New York City.
  • Professor Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, Director of Northern Region Interventional Radiology Service at Auckland City Hospital in Auckland, New Zealand, is also a co-lead investigator for the SWING Trial.
  • Professor Varcoe recently presented SWING Trial 6-month data on October 11 as part of the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.
  • Surmodics is a leading provider of surface modification technologies for intravascular medical devices and chemical components for in vitro diagnostic immunoassay tests and microarrays.