Tortuosity

Efemoral Medical Granted Breakthrough Device Designation

Retrieved on: 
Wednesday, February 14, 2024
Survivor, Tortuosity, CMO, PAOD, LOS, Vascular disease, FDA, Quality of life, De novo, Foot, Leg, Entrepreneurship, CLTI, Health, Prognosis, Patient, Artery, Extremities, Diagnosis, Moyamoya disease, Pharmaceutical industry

LOS ALTOS, Calif., Feb. 14, 2024 /PRNewswire/ -- Efemoral Medical, developer of advanced interventional bioresorbable therapies, today announced that the United States Food & Drug Administration (FDA) has granted its novel Efemoral Vascular Scaffold System (EVSS) Breakthrough Device status for the treatment of de novo or restenotic lesions of the infrapopliteal arteries in patients with Chronic Limb Threatening Ischemia (CLTI).

Key Points: 
  • LOS ALTOS, Calif., Feb. 14, 2024 /PRNewswire/ -- Efemoral Medical , developer of advanced interventional bioresorbable therapies, today announced that the United States Food & Drug Administration (FDA) has granted its novel Efemoral Vascular Scaffold System (EVSS) Breakthrough Device status for the treatment of de novo or restenotic lesions of the infrapopliteal arteries in patients with Chronic Limb Threatening Ischemia (CLTI).
  • The device designed for above-the-knee (femoropopliteal) intervention is currently being tested in a first-in-human trial, EFEMORAL I, in investigative sites in New Zealand and Australia.
  • Encouraged by the early clinical results, Efemoral Medical is now developing an additional device for treating below-the-knee (infrapopliteal) arteries in patients with CLTI.
  • We are extremely gratified that the FDA has recognized the potential of the EVSS to benefit these patients by granting Breakthrough Device status to our device."

Surmodics Announces Successful First Patient Use of Sublime™ Radial Access Microcatheter Designed for the Periphery

Retrieved on: 
Wednesday, April 19, 2023
General Health, Medical Devices, Other Health, Health, Cardiology, Stackable switch, Torque, Artery, DRS, Libin Cardiovascular Institute, Patient, Physician, Tortuosity, Wood drying, Pharmaceutical industry

Lodha and Nair are interventional cardiologists at the Cardiovascular Institute of the South.

Key Points: 
  • Lodha and Nair are interventional cardiologists at the Cardiovascular Institute of the South.
  • The Sublime portfolio will include the industry’s first suite of 0.014”, 0.018”, and 0.035” high-performance peripheral microcatheters.
  • “For peripheral as well as coronary interventions, radial access is safer than femoral access and much preferred by patients,” said Dr. Lodha.
  • The microcatheters are available in straight or angled tip configurations to access all types of peripheral vessels within their indicated size range.

Efemoral Medical Awarded Phase II SBIR Grant from NIH to Advance Treatment for Peripheral Artery Disease

Retrieved on: 
Thursday, September 22, 2022
Disability, National, LOS, Tortuosity, Peripheral artery disease, Entrepreneurship, Moyamoya disease, National Heart, Lung, and Blood Institute, Economics, Publication, PAD, Restenosis, United, CMO, Patient, Amputation, Lung, CEO, Technology, SBIR, Research, Vascular disease, R, Small business, Leg, Artery, Multimedia, Failure, Recurrence, Pharmaceutical industry, Medical device, Medical imaging, MD

LOS ALTOS, Calif., Sept. 22, 2022 /PRNewswire/ -- Efemoral Medical, developer of advanced interventional bioresorbable therapies, announced today that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Institutes of Health. SBIR grants are intended to stimulate technological innovation and encourage small United States businesses to engage in R&D with the potential for commercialization. The objective of Phase II grants is to continue the R&D efforts started under Phase I, in which the technical merit, feasibility, commercial potential of a project, and the quality of performance of the small business awardee have been established. Funds from Efemoral's award will be applied towards conducting studies aimed at characterizing the pre-clinical safety, efficacy, and foundational mechanism of action of its unique device.

Key Points: 
  • LOS ALTOS, Calif., Sept. 22, 2022 /PRNewswire/ -- Efemoral Medical , developer of advanced interventional bioresorbable therapies, announced today that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Institutes of Health.
  • SBIR grants are intended to stimulate technological innovation and encourage small United States businesses to engage in R&D with the potential for commercialization.
  • "Current treatment options for patients with peripheral occlusive disease are woeful as early failures are common and the results continue to degrade over time," said Lewis B. Schwartz, MD, Co-Founder and CMO of Efemoral Medical.
  • Efemoral Medical, Inc. is developing next-generation bioresorbable solutions to treat patients with vascular disease.

FDA Clears Four New Coronary Micro Support Catheters

Retrieved on: 
Tuesday, April 12, 2022
Plaque, Percutaneous coronary intervention, Torque, Federal Food, Drug, and Cosmetic Act, Multimedia, PARK, PCI, CEO, CTO, View, CE marking, Industry, Technology, CAD, Tortuosity, XO, PAD, Solution, CLI, FDA, Calcification, Patient, Peripheral artery disease, Pharmaceutical industry

PARK CITY, Utah, April 12, 2022 /PRNewswire/ -- Transit Scientific announced the FDA clearance of its XO Cross® Support Catheter Platform to include coronary use. The platform is indicated to guide and support a guidewire during access of the peripheral or coronary vasculature, allow for wire exchanges, and provide a conduit for delivery of saline solutions or diagnostic contrast agents. 

Key Points: 
  • Non-tapered metal-alloy support catheter platform receives FDA clearance for use in coronary and peripheral vasculature.
  • Transit Scientific now has one of the largest platforms of FDA cleared microcatheters in the industry.
  • PARK CITY, Utah, April 12, 2022 /PRNewswire/ -- Transit Scientific announced the FDA clearance of its XO CrossSupport Catheter Platform to include coronary use.
  • The platform is indicated to guide and support a guidewire during access of the peripheral or coronary vasculature, allow for wire exchanges, and provide a conduit for delivery of saline solutions or diagnostic contrast agents.

Biomodex® Announces Launch of Clear Cartridges for Neurovascular Training

Retrieved on: 
Thursday, March 31, 2022
Adoption, Medicine, 3D, ICE, Grand Rapids Medical Mile, MD, Viscosity, TEE, Stroke, Tortuosity, Physician, VP, Medical imaging

BOSTON, March 31, 2022 /PRNewswire/ -- Biomodex®, the leader in biorealistic haptic simulators for physician training and rehearsals, today announced the launch of Clear Cartridges for use with all Biomodex EVIAS™ and EVIAS Plus™ stations. The anatomically accurate clear cartridges are 3D printed using a transparent material that allows physicians to train for ischemic stroke and unruptured aneurysm procedures outside the catheterization lab setting.

Key Points: 
  • BOSTON, March 31, 2022 /PRNewswire/ -- Biomodex , the leader in biorealistic haptic simulators for physician training and rehearsals,today announced the launch of Clear Cartridges for use with all Biomodex EVIAS and EVIAS Plus stations.
  • The anatomically accurate clear cartridges are 3D printed using a transparent material that allows physicians to train for ischemic stroke and unruptured aneurysm procedures outside the catheterizationlab setting.
  • Biomodex's standard cartridges are used with imaging in the catheterizationlab, but the clear cartridges are transparent and can be used without imaging, allowing for tabletop training and demonstrations.The clear cartridges are available in a range of anatomies and have been designed to offer varying degrees of complexity and tortuosity to support iterative training programs with varying degrees of difficulty.
  • The clear cartridges connect directly with the Biomodex EVIAS station which replicates blood flow and viscosity to provide a complete simulation experience.