Femoral vein

The Medtronic Sphere-360™ Pulse Field Ablation (PFA) catheter, a new paradigm in single-shot ablation, demonstrates impressive results in treating paroxysmal atrial fibrillation

Retrieved on: 
Monday, April 8, 2024
Freedom, Atrial fibrillation, Risk, Patient, Stroke, PFA, Medtronic, Femoral vein, Pulse, Heart failure, Ventricular fibrillation, MPH, Index, Heart, Safety, AAD, Annual general meeting, Cardiac tamponade, Pulmonary vein stenosis

DUBLIN and BERLIN, April 8, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical trial safety and efficacy results for Sphere-360™, an investigational single-shot mapping and ablation catheter using pulsed field (PF) energy, for treatment of patients with paroxysmal atrial fibrillation (AFib). Interim findings from the first-in-human Sphere-360 study were presented as a late-breaking clinical trial at the European Heart Rhythm Association (EHRA) 2024 Annual Meeting.

Key Points: 
  • Interim findings from the first-in-human Sphere-360 study were presented as a late-breaking clinical trial at the European Heart Rhythm Association (EHRA) 2024 Annual Meeting.
  • The Sphere-360 catheter was developed with the goal to simplify the atrial fibrillation procedure while enhancing efficiency and providing high durability of lesions.
  • Furthermore, the catheter is fully integrated with the Affera™ Mapping and Ablation System for complete visualization inside the heart and electroanatomical mapping, making it a true all-in-one single-shot catheter for mapping, ablation, and validation.
  • "These results are very encouraging as they show the Sphere-360 catheter has the potential to be an important part of next generation AFib care."

Kim Byoung Joon LEDAS Varicose Vein Clinic Becomes the First Organization to be Accredited under GHA Standards for Medical Travel 5.0

Retrieved on: 
Thursday, February 15, 2024
PALM, EVLA, Hospital, Patient satisfaction, Excellence, Health, Femoral vein, Patient, Medical tourism, Safety, Varicose veins, Certification, Accreditation, BEACH, GHA, Trust, Sclerotherapy, JCI, Insurance, Nursing

Kim Byoung Joon LEDAS Varicose Vein Clinic is the first healthcare provider to be accredited under GHA Standards 5.0, the most recent version of GHA's standards for medical travel.

Key Points: 
  • Kim Byoung Joon LEDAS Varicose Vein Clinic is the first healthcare provider to be accredited under GHA Standards 5.0, the most recent version of GHA's standards for medical travel.
  • Kim Byoung Joon LEDAS Varicose Vein Clinic (LEDAS) is known for its excellent vascular treatment services for varicose veins, using the latest technologies such as EVLA, ultrasound-guided sclerotherapy, and sclerotherapy.
  • It is the first varicose vein specialty clinic in Korea to be certified by GHA, emphasizing its commitment to quality and patient experience.
  • Dr. Kim Byoung Joon, the representative director of LEDAS clinic, is a renowned thoracic surgeon with over 23,000 clinical cases of varicose vein treatment experience in 26 years.

Kim Byoung Joon LEDAS Varicose Vein Clinic Becomes the First Organization to be Accredited under GHA Standards for Medical Travel 5.0

Retrieved on: 
Thursday, February 15, 2024
PALM, EVLA, Hospital, Patient satisfaction, Excellence, Health, Femoral vein, Patient, Medical tourism, Safety, Varicose veins, Certification, Accreditation, BEACH, GHA, Trust, Sclerotherapy, JCI, Insurance, Nursing

Kim Byoung Joon LEDAS Varicose Vein Clinic is the first healthcare provider to be accredited under GHA Standards 5.0, the most recent version of GHA's standards for medical travel.

Key Points: 
  • Kim Byoung Joon LEDAS Varicose Vein Clinic is the first healthcare provider to be accredited under GHA Standards 5.0, the most recent version of GHA's standards for medical travel.
  • Kim Byoung Joon LEDAS Varicose Vein Clinic (LEDAS) is known for its excellent vascular treatment services for varicose veins, using the latest technologies such as EVLA, ultrasound-guided sclerotherapy, and sclerotherapy.
  • It is the first varicose vein specialty clinic in Korea to be certified by GHA, emphasizing its commitment to quality and patient experience.
  • Dr. Kim Byoung Joon, the representative director of LEDAS clinic, is a renowned thoracic surgeon with over 23,000 clinical cases of varicose vein treatment experience in 26 years.

Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System

Retrieved on: 
Wednesday, January 31, 2024
Atrial fibrillation, Femoral vein, Heart, Atrial flutter, Clinical trial, Food and Drug Administration, Patient, Safety, PFA, CDRH, Boston, ADVENT, Chosen-ciphertext attack, FDA, Boston Scientific, CTI, Device, Food, Physician, AVANT, CE marking, BSX, Pulmonary vein stenosis, Medical imaging

MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment.

Key Points: 
  • Strong clinical evidence base, largest volume of real-world use reinforce safety, efficacy and efficiency advantages of the system
    MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System.
  • "The approval of the FARAPULSE PFA System marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the U.S.," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific.
  • The FARAPULSE PFA System, however, relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures.
  • The company is developing a navigation-enabled version of the FARAWAVE catheter alongside the FARAVIEW™ Software Module and anticipates regulatory approval in 2024.

Cryofocus Medtech Obtains NMPA Approval for the AF Cryoablation System

Retrieved on: 
Tuesday, December 12, 2023
Necrosis, Hypertension, Republic, Nitrous oxide, Temperature, NMPA, Femoral vein, National Medical Products Administration, Patient, Safety, NOTES, Atrial fibrillation, Pharmaceutical industry

The AF Cryoablation System of Cryofocus Medtech, consisting of the cryoablation equipment, the balloon cryoablation catheter, the disposable intracardiac mapping catheter and the adjustable curved guide catheter, is the first cardiac product that applies cryoballoon with liquid nitrogen as the refrigerant for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.

Key Points: 
  • The AF Cryoablation System of Cryofocus Medtech, consisting of the cryoablation equipment, the balloon cryoablation catheter, the disposable intracardiac mapping catheter and the adjustable curved guide catheter, is the first cardiac product that applies cryoballoon with liquid nitrogen as the refrigerant for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.
  • The approval of the AF Cryoablation System in China markets marks an important milestone in the business development of Cryofocus Medtech in vascular interventional cryotherapy.
  • Meanwhile, the Company's Asthma Cryoablation System and COPD Cryospray System entered into the confirmatory clinical trial phase in March 2023.
  • In addition, as of June 30, 2023, Cryofocus Medtech submitted the registration application for the Cryoadhesion System, and it is expected to obtain approval from the NMPA for the product in the first quarter of 2024.

Endologix announces the U. S. Centers for Medicare & Medicaid Services granted a Transitional Pass-Through (TPT) Payment for the DETOUR™ System

Retrieved on: 
Wednesday, December 27, 2023
General Health, FDA, Medical Devices, Hospitals, Health, Physician, Femoral vein, Vascular disease, Hospital, MD, OPPS, Therapy, C1604, Medicare, TPT, Patient, Diagnosis, Leg, PMA, PTAB, CMS, PAD, Pharmaceutical industry

Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announces that the U. S. Centers for Medicare & Medicaid Services (CMS) granted a Transitional Pass-Through (TPT) Payment for the DETOUR System, effective January 1, 2024.

Key Points: 
  • Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announces that the U. S. Centers for Medicare & Medicaid Services (CMS) granted a Transitional Pass-Through (TPT) Payment for the DETOUR System, effective January 1, 2024.
  • The TPT Payment was created to facilitate patient access for qualifying new medical technologies that substantially improve the diagnosis or treatment of Medicare beneficiaries.
  • TPT will provide hospitals with additional device reimbursement when the DETOUR System is used for eligible cases in the hospital outpatient setting.
  • Percutaneous Transmural Arterial Bypass (PTAB) with the DETOUR System, an FDA Breakthrough Device, received PMA approval in June 2023.

Pulse Biosciences Announces First-in-Human Procedures with its Novel CellFX™ Nanosecond Pulsed Field Ablation (nsPFA™) Cardiac Catheter

Retrieved on: 
Wednesday, December 20, 2023
Medical Devices, Hospitals, Clinical Trials, Cardiology, Biotechnology, Radiology, Health, Pharmaceutical, General Health, Patient, PFA, Physician, Research, FDA, Mount Sinai Hospital, 3D, Catheter, Electrophysiology, Femoral vein, Safety, Atrial fibrillation, Medical device

Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the completion of the first five procedures in its first-in-human feasibility study with its novel CellFX nsPFA cardiac catheter.

Key Points: 
  • Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the completion of the first five procedures in its first-in-human feasibility study with its novel CellFX nsPFA cardiac catheter.
  • The catheter is designed to deliver a fast, transmural and fully circumferential ablation in a single energy delivery.
  • The CellFX nsPFA cardiac catheter is integrated with 3D mapping and navigation to deliver a comprehensive visualization and precise ablation delivery solution.
  • The observations to date have been positive but the broad set of risks associated with cardiac surgery remain.

Endologix Announces Results of Pooled Analysis of DETOUR1 and DETOUR2 Studies at 2023 VIVA Late-Breaking Clinical Trial Session

Retrieved on: 
Thursday, November 2, 2023
Health, Medical Devices, Health Technology, Clinical Trials, Research, Science, Cardiology, Maes, Length of stay, Vascular disease, SFA, Physician, MD, Safety, Cleveland, Arnold, Leg, PE, DVT, Femoral vein, Freedom, VIVA, TVR, PTAB, Patient, PAD, Medical imaging, Airline

Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multi-center, international studies designed to evaluate the DETOUR System.

Key Points: 
  • Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multi-center, international studies designed to evaluate the DETOUR System.
  • For the pooled analysis, primary patency was defined as freedom from target vessel revascularization (TVR).
  • “We are pleased to present the combined results of the DETOUR1 and DETOUR2 Studies.
  • Safety and Performance of percutaneous Transmural Femoropopliteal Bypass with the DETOUR System: Pooled analysis of DETOUR1 and DETOUR2.

LimFlow Announces Agreement to Be Acquired by Inari Medical

Retrieved on: 
Wednesday, November 1, 2023
Cardiology, Radiology, Surgery, Health, FDA, Medical Devices, Clinical Trials, Other Health, Peripheral artery disease, Femoral vein, Chronic limb threatening ischemia, CLTI, MD, Acquisition, Sofinnova, Leg, Growth, The New England Journal of Medicine, Amputation, Transcatheter arterial chemoembolization, Pain, Patient, PAD, Wound healing, Pharmaceutical industry, Nursing

The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.

Key Points: 
  • The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.
  • "We are thrilled to join forces with Inari Medical, expanding the reach of our remarkable technology to bring renewed hope to patients who are currently suffering," said LimFlow CEO Dan Rose.
  • "Our heartfelt gratitude goes out to the exceptional LimFlow team, our dedicated clinical partners, and our investors who believed in our mission.
  • “The acquisition of LimFlow is closely aligned with our mission to address significant unmet patient needs and adds another highly differentiated growth platform into our portfolio,” said Drew Hykes, CEO of Inari.

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

Retrieved on: 
Wednesday, November 1, 2023
Female, Blood vessel, Maes, Kidney disease, Education, DCB, Freedom, MAE, TASC, Safety, Diabetes, Kaplan–Meier estimator, Research, Subgroup analysis, Meta-analysis, Pulmonary embolism, Death, BD, DVT, Detour, Clinical trial, Hypertension, Femoral vein, VIVA, TVR, Amputation, PTAB, Patient, Wynn Las Vegas, TLR, Medical imaging, Birth control, Pharmaceutical industry, Airline, SFA, Torus, EU

Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.
  • A total of 1,005 patients at 74 investigational sites were treated with the Lutonix 035 DCB and were followed to 36 months.
  • Freedom from TLR at 12 months was 88.6%, and freedom from primary safety events at 30 days was 98.2%.
  • DETOUR clinical data demonstrate the clinical utility of this novel therapy in long femoropopliteal lesions.