Angioplasty

FDA Clears Innovative Angioplasty Scoring and Cutting Platform

Retrieved on: 
Thursday, June 4, 2020
Medicine, Clinical medicine, Interventional radiology, Angioplasty, Fistula, Arteriovenous, Percutaneous, Popliteal, Balloon, PTA

PARK CITY, Utah, June 4, 2020 /PRNewswire/ --Transit Scientific announced the FDA cleared the XO ScorePercutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic and/or native arteriovenous hemodialysis fistula.

Key Points: 
  • PARK CITY, Utah, June 4, 2020 /PRNewswire/ --Transit Scientific announced the FDA cleared the XO ScorePercutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic and/or native arteriovenous hemodialysis fistula.
  • Calcified, fibrous, and/or resilient stenosis may require special scoring or cutting angioplasty balloons with integrated wires or blades on the balloon.The added features focus and improve dilating force but result in large crossing profiles and limited deliverability while increasing cost and inventory.
  • "XO Score transforms regular PTA balloons into scoring and cutting systems," said Greg Method, President, Transit Scientific, Park City, Utah.
  • "Rotating struts allow clinicians to vary scoring depth without increasing device profile.Economically, XO Score offers a direct value proposition:(1) XO Score + (1) off-the-shelf PTA balloon will cost less than (1) specialty PTA scoring or cutting technology."

European Peripheral Vascular Devices Market Report Suite, 2020-2026 - ResearchAndMarkets.com

Retrieved on: 
Friday, May 29, 2020
Health, Medical devices, Cardiology, Medicine, Medical specialties, Clinical medicine, Atherectomy, Angioplasty, Percutaneous, Stent, Balloon catheter, Embolization, Catheter, Cordis

The "Peripheral Vascular Devices Market Report Suite: Europe 2020-2026 - MedSuite" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Peripheral Vascular Devices Market Report Suite: Europe 2020-2026 - MedSuite" report has been added to ResearchAndMarkets.com's offering.
  • The European peripheral vascular device market was valued at about 1.3 billion in 2019.
  • This is expected to increase over the forecast period at a CAGR of 2.9% to reach about 1.6 billion by 2026.
  • The full report suite on the European market for peripheral vascular (PV) devices includes peripheral arterial stents, peripheral venous stents, percutaneous transluminal angioplasty (PTA) balloon catheters, atherectomy devices, chronic total occlusion (CTO) devices, embolic protection devices (EPDs), stent grafts, surgical grafts, arteriovenous (AV) access thrombectomy devices, inferior vena cava filters, diagnostic and interventional catheters, standard and hydrophilic guidewires, introducer sheaths, vascular closure devices (VCDs) and transcatheter embolization devices.

Alucent Biomedical Announces First Patient Enrolled in Phase 1 Natural Vascular Scaffolding Clinical Trial

Retrieved on: 
Wednesday, May 27, 2020
Biotechnology, Pharmaceutical, Health, FDA, Medical devices, Hospitals, Clinical trials, Other Health, NVS, Angioplasty

announced that it has enrolled the first two patients in ACTIVATE I, a Phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology .

Key Points: 
  • announced that it has enrolled the first two patients in ACTIVATE I, a Phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology .
  • The Alucent NVS Vessel Restoration System with Photoactivated Linking combines standard angioplasty with linking of the structural proteins in the wall of a blood vessel.
  • Alucent NVS photoactivated linking is also designed to mitigate the well-known adverse effects of angioplasty, such as vessel recoil.
  • Founded in 2017, Alucent Biomedical is a privately held biomedical company dedicated to developing and commercializing its breakthrough Natural Vascular Scaffolding (NVS) technology for the treatment of vascular disease.

Intact Vascular Announces Publication of TOBA III Clinical Trial Results in the Journal of Vascular Surgery

Retrieved on: 
Wednesday, May 13, 2020
Research, Surgery, Medical devices, Clinical trials, Cardiology, Other Health, Health, Other Science, Science, Medicine, Medical specialties, Clinical medicine, Vascular surgery, Angioplasty, Minimally invasive procedure, Surgical Outcomes Analysis and Research, Rajiv Parakh

Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the peer-reviewed publication of its Tack Optimized Balloon Angioplasty (TOBA) III 12-month clinical trial results in the Journal of Vascular Surgery.

Key Points: 
  • Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the peer-reviewed publication of its Tack Optimized Balloon Angioplasty (TOBA) III 12-month clinical trial results in the Journal of Vascular Surgery.
  • The trial results were previously presented as part of the High Impact Clinical Research session during the 2019 Transcatheter Cardiovascular Therapeutics (TCT) conference.
  • We are thrilled to have the TOBA III data published in the Journal of Vascular Surgery, commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular.
  • Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III.

U.S. Peripheral Vascular Devices Market 2020-2026: Trends & Developments, Procedure Numbers, Competitive Analysis

Retrieved on: 
Wednesday, May 6, 2020
Interventional radiology, Medicine, Medical specialties, Clinical medicine, Atherectomy, Angioplasty, Peripheral artery disease, Stent, Intravascular ultrasound, Embolization, Percutaneous, Catheter

DUBLIN, May 6, 2020 /PRNewswire/ -- The "Peripheral Vascular Devices Market Report Suite | United States | 2020-2026 | MedSuite" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, May 6, 2020 /PRNewswire/ -- The "Peripheral Vascular Devices Market Report Suite | United States | 2020-2026 | MedSuite" report has been added to ResearchAndMarkets.com's offering.
  • One of the greatest limitations in this market is the pricing pressure that is occurring within the office-based lab (OBL) setting.
  • This report on the U.S. market for peripheral vascular devices includes peripheral vascular stents, venous stents, percutaneous transluminal angioplasty (PTA) balloon catheters, drug-coated balloons (DCBs), atherectomy devices, intravascular lithotripsy, chronic total occlusion (CTO) devices, surgical grafts, stent grafts, embolic protection devices (EPDs), peripheral thrombus management devices, inferior vena cava filters (IVCFs) and retrieval devices, carotid shunts, transcarotid arterial revascularization (TCAR) flow reversal systems and stents, diagnostic and interventional catheters, diagnostic and interventional guidewires, introducer sheaths, vascular closure devices (VCDs), transcatheter embolization devices and peripheral IVUS catheters.
  • Many of these devices can be used for treating either coronary arterial disease or peripheral arterial disease (PAD).

United States Peripheral Vascular Devices Market Report 2020-2026 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 6, 2020
Medical devices, Health, Medicine, Interventional radiology, Medical specialties, Clinical medicine, Atherectomy, Stent, Angioplasty, Intravascular ultrasound, Percutaneous, Balloon catheter, Embolization, Catheter

The "Peripheral Vascular Devices Market Report Suite | United States | 2020-2026 | MedSuite" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Peripheral Vascular Devices Market Report Suite | United States | 2020-2026 | MedSuite" report has been added to ResearchAndMarkets.com's offering.
  • One of the greatest limitations in this market is the pricing pressure that is occurring within the office-based lab (OBL) setting.
  • This report on the U.S. market for peripheral vascular devices includes peripheral vascular stents, venous stents, percutaneous transluminal angioplasty (PTA) balloon catheters, drug-coated balloons (DCBs), atherectomy devices, intravascular lithotripsy, chronic total occlusion (CTO) devices, surgical grafts, stent grafts, embolic protection devices (EPDs), peripheral thrombus management devices, inferior vena cava filters (IVCFs) and retrieval devices, carotid shunts, transcarotid arterial revascularization (TCAR) flow reversal systems and stents, diagnostic and interventional catheters, diagnostic and interventional guidewires, introducer sheaths, vascular closure devices (VCDs), transcatheter embolization devices and peripheral IVUS catheters.
  • However, only devices used for peripheral procedures are included in this report.

ZOLL TherOx Receives CE Mark Approval for SuperSaturated Oxygen Therapy

Retrieved on: 
Monday, May 4, 2020
Professional services, Veterinary, Stem cells, Nursing, Practice Management, Medical Supplies, Other Health, Physical therapy, FDA, Managed care, Diabetes, Radiology, General Health, Optical, Oncology, Mental health, Medical devices, Infectious diseases, Hospitals, Genetics, Fitness & Nutrition, Dental, Clinical trials, Cardiology, Biotechnology, Alternative medicine, AIDS, Health, Other Professional Services, Surgery, Medicine, Health, Clinical medicine, Interventional radiology, Medical equipment, Vascular surgery, Medical devices, Revascularization, Zoll, Angioplasty, Stent, Hyperbaric medicine, ZOLL Medical Corporation, Asahi Kasei

ZOLL Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today it has received CE Mark approval to market and distribute its SuperSaturated Oxygen (SSO2) Therapy System in Europe.

Key Points: 
  • ZOLL Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today it has received CE Mark approval to market and distribute its SuperSaturated Oxygen (SSO2) Therapy System in Europe.
  • View the full release here: https://www.businesswire.com/news/home/20200504005373/en/
    SSO2 Therapy will support clinicians in delivering the highest quality of care for their STEMI patients in Europe and other countries that accept CE Mark, said Neil Johnston, President, ZOLL Circulation.
  • SSO2 Therapy delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization via angioplasty and stenting of the blocked coronary artery.
  • TherOx and ZOLL are trademarks and/or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries.

Modern Vascular Among First Medical Facilities in the Country to Perform Post-Angioplasty Dissection Repair Below The Knee with Newly FDA-Approved Tack Endovascular System®

Retrieved on: 
Thursday, April 23, 2020
Medicine, Medical specialties, Clinical medicine, Interventional radiology, Angioplasty, Vascular surgery, Percutaneous, Minimally invasive procedure, Cordis

Todays outpatient procedure was performed by Dr. Scott Brannan, Chief of Endovascular Surgery, at Modern Vasculars clinic in North Mesa, Arizona.

Key Points: 
  • Todays outpatient procedure was performed by Dr. Scott Brannan, Chief of Endovascular Surgery, at Modern Vasculars clinic in North Mesa, Arizona.
  • Dr. Brannan and Modern Vascular have been working with us for almost six months now," says Todd Royal, Territory Director at Intact Vascular.
  • Balloon Angioplasty, also referred to as Percutaneous Transluminal Angioplasty (PTA), is a minimally invasive and effective treatment for PAD and CLI.
  • The Tack Endovascular System is uniquely designed to preserve the vessel, minimize vessel inflammation, and enhance blood flow.

Tack Endovascular System® Receives FDA Approval for Below-the-Knee Post-Angioplasty Dissection Repair

Retrieved on: 
Tuesday, April 14, 2020
Health, FDA, Medical devices, Surgery, Other Health, Clinical trials, Biotechnology, Interventional radiology, Angioplasty, Vascular surgery

The Tack Endovascular System is designed to repair dissections following peripheral balloon angioplasty.

Key Points: 
  • The Tack Endovascular System is designed to repair dissections following peripheral balloon angioplasty.
  • Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III.
  • Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty.
  • Tack Endovascular System and Tack are registered trademarks of Intact Vascular, Inc.

SHOCKWAVE COMPLETES ENROLLMENT IN PIVOTAL STUDY FOR CORONARY INTRAVASCULAR LITHOTRIPSY

Retrieved on: 
Monday, April 6, 2020
Medicine, Circulatory system, Medical specialties, Interventional radiology, Medical devices, Coronary artery disease, RTT, Stent, Coronary, Angioplasty, Percutaneous coronary intervention

DISRUPT CAD III is a prospective, multicenter, single-arm, global IDE study to demonstrate the safety and effectiveness of the Shockwave Coronary IVL System with the Shockwave C2 Coronary IVL Catheter in de novo, calcified, stenotic, coronary arteries prior to stenting.

Key Points: 
  • DISRUPT CAD III is a prospective, multicenter, single-arm, global IDE study to demonstrate the safety and effectiveness of the Shockwave Coronary IVL System with the Shockwave C2 Coronary IVL Catheter in de novo, calcified, stenotic, coronary arteries prior to stenting.
  • The study enrolled 384 patients, exceeding the minimum requirement of 372 patients, per the a priori statistical plan agreed by the FDA.
  • Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies; they are limited to investigational use in the United States.
  • Shockwave Medical is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated.