Arteriovenous fistula

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Retrieved on: 
Tuesday, April 2, 2024
Chronic kidney disease, DCB, Kidney disease, Patient, Arteriovenous fistula, IDE, Sirolimus, Quality of life, Trial of the century, Fistula, Clinical trial, Kidney, AVF, PMA, US FDA, Safety, Food, FDA, Health, Pharmaceutical industry

Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

Key Points: 
  • Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
  • The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.
  • This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V.
  • With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients' lives worldwide.

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Retrieved on: 
Tuesday, April 2, 2024
Chronic kidney disease, DCB, Kidney disease, Patient, Arteriovenous fistula, IDE, Sirolimus, Quality of life, Trial of the century, Fistula, Clinical trial, Kidney, AVF, PMA, US FDA, Safety, Food, FDA, Health, Pharmaceutical industry

Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

Key Points: 
  • Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
  • The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.
  • This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V.
  • With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients' lives worldwide.

First U.S. Implantation of VasQ™ Since FDA De Novo was Granted

Retrieved on: 
Tuesday, January 16, 2024
Mortality, Patient, Fistula, Gilon, Health, Risk, CVC, COVID-19, Lamination, Infection, Central venous catheter, Arteriovenous fistula, Medical imaging

SPARTANBURG, S.C., Jan. 16, 2024 /PRNewswire/ -- The first U.S. implantation of VasQ™ since FDA De Novo was granted was successfully performed by Dr. Ari Kramer, Director and principal surgeon of Vascular Access Surgery at Spartanburg Regional Hospital in Spartanburg, SC.

Key Points: 
  • SPARTANBURG, S.C., Jan. 16, 2024 /PRNewswire/ -- The first U.S. implantation of VasQ™ since FDA De Novo was granted was successfully performed by Dr. Ari Kramer, Director and principal surgeon of Vascular Access Surgery at Spartanburg Regional Hospital in Spartanburg, SC.
  • VasQ is a nitinol-based external support device for the artery and vein anastomosis during the surgical creation of an arteriovenous fistula to promote maturation into a functional access for hemodialysis.
  • The device was designed to provide structural reinforcement of the mobilized vessels and guides a more stable arterial flow profile as it transitions into the vein.
  • Creating more functional fistulas with the assistance of a device like VasQ should help to reduce the CVC exposure for this patient population.

Alucent Biomedical Receives Regulatory Approval for Second U.S. Clinical Study

Retrieved on: 
Tuesday, November 7, 2023
Medical Devices, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Trial of the century, Ioctl, AVF, Vascular remodelling in the embryo, Physician, Kidney failure, AV, IDE, Dialysis, Arteriovenous fistula, Fistula, Patient, Activate, Medical device

Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration (FDA) granted an Investigational Device Exemption (IDE) for a U.S. clinical study of its AlucentNVS technology for promoting the maturation of arteriovenous fistulas (AVF) in patients requiring hemodialysis.

Key Points: 
  • Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration (FDA) granted an Investigational Device Exemption (IDE) for a U.S. clinical study of its AlucentNVS technology for promoting the maturation of arteriovenous fistulas (AVF) in patients requiring hemodialysis.
  • The milestone follows Alucent’s first IDE approval from the FDA, which was granted in August 2023.
  • AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling.
  • The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow.

Fresenius Medical Care Demonstrates Commitment to Innovating Dialysis and Kidney Disease Care with Presentations at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Tuesday, October 31, 2023
Kidney, Frankfurt Stock Exchange, Patient, Hemofiltration, Research, FME, Intelligence, III, HDF, Assessment of kidney function, AVF, Big data, Fatigue, HD, American Society of Nephrology, Saskatchewan River Sturgeon Management Board, Arteriovenous fistula, FX, Health, Society, Artificial intelligence, Dialysis, PO4, PSM, COVID-19, ASN, Machine learning, Congress, Fresenius Medical Care, FKC, RBV, Creatinine, Scientific Committee on Oceanic Research, FMS, Peritoneum, IDS, Data science, Pharmaceutical industry, Medical device, Hemodialysis, Nephrology

Fresenius Medical Care announces presentations at the American Society of Nephrology (ASN) Kidney Week 2023.

Key Points: 
  • Fresenius Medical Care announces presentations at the American Society of Nephrology (ASN) Kidney Week 2023.
  • Scientific and medical experts from across Fresenius Medical Care will present research related to many important topics in kidney disease care.
  • Through its network of 4,050 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approximately 344,000 patients around the globe.
  • Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

The VasQ™ External Support Now FDA Cleared for Use in Creating Arteriovenous Fistulas

Retrieved on: 
Wednesday, September 27, 2023
Infection, Surgeon, Lamination, Freedom, De novo, Hospital, CVC, Ioctl, National Institutes of Health Clinical Center, Dialysis, TEL, Journal, Patient, Physician, Arteriovenous fistula, Journal of Vascular and Interventional Radiology, FDA, AVF, Vascular surgery, Safety, Fistula, Medical imaging

TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ -- Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access.

Key Points: 
  • TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ -- Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access.
  • No serious adverse event associated with the device was reported over the 2-year study.
  • Additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study reported statistically superior rates of functional success (confirmed use of the AVF for dialysis) and reduced need for additional procedures.
  • VasQ is a nitinol-based device implanted around the artery and vein during the surgical creation of an arteriovenous fistula.

Merit Medical’s WRAPSODY™ Arteriovenous Access Efficacy (WAVE) Pivotal Study Completes Enrollment

Retrieved on: 
Thursday, August 3, 2023
Maintenance, Investigational device exemption, AVG, Bachelor of Medicine, Bachelor of Surgery, Ioctl, MMSI, AVG Technologies, Sale, Blood, Food and Drug Administration Amendments Act of 2007, FRCR, PMA, Data analysis, FSVM, WAVE, MD, Patient, Physician, Queen Elizabeth Hospital Birmingham, European, AV, United Kingdom, MRCP, Trial of the century, IDE, Occlusion, FDA, CIE, Queen Elizabeth Hospital, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, AVF, Arteriovenous fistula, Food, Safety, Pharmaceutical industry, Medical device, Merit

SOUTH JORDAN, Utah, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the completion of enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study.

Key Points: 
  • SOUTH JORDAN, Utah, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the completion of enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study.
  • Creation and maintenance of an arteriovenous fistula or graft (AVF/AVG) to achieve long-term vascular access (access to blood vessels) is required for patients undergoing hemodialysis.
  • Merit intends to collect safety and efficacy outcomes throughout the study follow-up period.
  • Merit intends to follow patients enrolled in the WAVE study for 24 months following completion of enrollment.

Alucent Biomedical Wins FDA Approval for U.S. Clinical Study

Retrieved on: 
Wednesday, August 2, 2023
Medical Devices, FDA, Health, Clinical Trials, Cardiology, Biotechnology, PAD, Trial of the century, Standard of care, Patient, Vascular disease, Coronary, Peripheral artery disease, Vascular remodelling in the embryo, Arteriovenous fistula, IDE, AVF, Medical imaging

Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.

Key Points: 
  • Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.
  • AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling.
  • The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow.
  • “IDE approval by the FDA’s Division of Coronary and Peripheral Interventional Devices is another validation of our novel approach to treating vascular disease,” said Dr. Myles Greenberg, CEO of Alucent Biomedical.

Global Hemodialysis Market Report 2022 to 2030 - Increasing Number of ESRD Patients is Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Wednesday, December 7, 2022
Medical Supplies, Medical Devices, Health, Diabetes, Managed Care, Biotechnology, PMP, Dialysis, Person, Hemodialysis, Government, International Diabetes Federation, ESRD, Kidney failure, Patient, Prevalence, Arteriovenous fistula, Chronic kidney disease, CKD, Incidence, Indian government response to the COVID-19 pandemic, Diabetes, COVID-19, Kidney, Hypertension, Fistula, IDF, USD, Medical device, Pharmaceutical industry

The global Hemodialysis market size is expected to reach USD 136.86 billion by 2030, according to a new study.

Key Points: 
  • The global Hemodialysis market size is expected to reach USD 136.86 billion by 2030, according to a new study.
  • The report gives a detailed insight into the current market dynamics and provides analysis on future market growth.
  • Renal failure and chronic kidney disease are becoming more common, which is one of the main drivers of market expansion.
  • Therefore, increasing ESRD prevalence is increasing the financial burden of kidney disorders globally and is a major driver of rising service revenue.

First Patient Enrolled in Merit Medical’s WRAPSODY™ Registry (WRAP) Study

Retrieved on: 
Tuesday, July 5, 2022
WRAP, Critical care, Patient, AVF, Arteriovenous fistula, CEO, PTFE, Dialysis, GLOBE, Endoscopy, Adapter, Sale, Hemodialysis, MMSI, CE marking, Blood, AVG, Stenosis, Cardiology, NASDAQ, Radiology, Hospital, Pharmaceutical industry, Medical device, Medicine

The WRAPSODY Cell-Impermeable Endoprosthesis was created to help overcome this challenge by maintaining the integrity of the dialysis outflow circuit.

Key Points: 
  • The WRAPSODY Cell-Impermeable Endoprosthesis was created to help overcome this challenge by maintaining the integrity of the dialysis outflow circuit.
  • Dr. Dean Huang, consultant diagnostic and interventional radiologist at Kings College Hospital in London, England, enrolled the first patient in the WRAP Registry.
  • The patients being treated with the WRAPSODY Cell-Impermeable Endoprosthesis have historically had few clinical options, Dr. Huang said.
  • The WRAP study will add to the growing body of evidence on WRAPSODYs ability to achieve durable outcomes for this vulnerable patient population.