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ISET 2025

First Clinical Use of a Novel Forward-Shifted Peripheral Intravascular Lithotripsy System: Primary Outcomes of the FORWARD IDE and Feasibility Studies

Daniel G. Clair, MD
03/17/2025

 

In this video, Dr Daniel Clair, chair of the Department of Vascular Surgery in the Section of Surgical Sciences at Vanderbilt University Medical Center, discusses the key findings of the single-arm, prospective, multicenter FORWARD PAD IDE trial and its feasability studies. This trial assessed the safety and efficacy of the Medical Mini S Peripheral IVL catheter, part of the Javelin Peripheral IVL Catheter system (Shockwave Medical), for the treatment of moderate to severely calcified lesions. 


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VentiV Clinical Images
Thrombectomy
FDA Clears New Mechanical Thrombectomy System
03/31/2025
VentiV Scientific announced the FDA clearance of VentiV Mechanical Thrombectomy system to remove blood clots from the peripheral vasculature including the new VentiV Pulse platform.
VentiV Scientific announced the FDA clearance of VentiV Mechanical Thrombectomy system to remove blood clots from the peripheral vasculature including the new VentiV Pulse platform.
VentiV Scientific announced the...
03/31/2025
Cath Lab Digest
Restenosis
Real-world Data Shows Cook’s Zilver PTX Leads to Lower Rates of In-stent Occlusion Than Boston Scientific’s Eluvia
03/27/2025
Bloomington, Ind. — Cook Medical’s Zilver PTX drug-eluting stent (DES) has lower rates of in-stent occlusions among patients with restenosis at 3 years than Boston Scientific’s Eluvia DES, according to real-world data from the REALDES study....
Bloomington, Ind. — Cook Medical’s Zilver PTX drug-eluting stent (DES) has lower rates of in-stent occlusions among patients with restenosis at 3 years than Boston Scientific’s Eluvia DES, according to real-world data from the REALDES study....
Bloomington, Ind. — Cook...
03/27/2025
Vascular Disease Management
TAVR
Medtronic’s Evolut Trial Outcome Could Shake Up US TAVR Market, Says GlobalData
03/21/2025
Medtronic has released results from the two-year point of a clinical trial comparing its Evolut to Edwards Lifesciences’ SAPIEN. The results revealed that the Evolut showed superior performance to the SAPIEN. Specifically, the Evolut showed...
Medtronic has released results from the two-year point of a clinical trial comparing its Evolut to Edwards Lifesciences’ SAPIEN. The results revealed that the Evolut showed superior performance to the SAPIEN. Specifically, the Evolut showed...
Medtronic has released results...
03/21/2025
Vascular Disease Management
Embolotherapy
Instylla Completes Submission of Premarket Approval Application for Embrace™ Hydrogel Embolic System
03/11/2025
BEDFORD, Mass., March 11, 2025 /PRNewswire/ -- Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration...
BEDFORD, Mass., March 11, 2025 /PRNewswire/ -- Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration...
BEDFORD, Mass., March 11, 2025...
03/11/2025
Vascular Disease Management
Resistant Hypertension
Corcept Therapeutics Initiates MOMENTUM Trial to Determine Prevalence of Hypercortisolism in Patients with Resistant Hypertension
03/10/2025
“Resistant hypertension is a serious public health challenge. Patients whose hypertension remains in poor control despite receiving optimal care, including multiple medications, are at greater risk of cardiovascular morbidity and mortality,”...
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“Resistant hypertension is a...
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Cath Lab Digest
Company expansion
Reflow Medical Expands Global Reach With New European Subsidiary
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Reflow Medical, Inc., a developer of innovative medical devices for complex cardiovascular disease, has announced the opening of its European subsidiary in Landsberg am Lech, Germany.
Reflow Medical, Inc., a...
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Cath Lab Digest
SCAI
Survey Confirms Radiation and Orthopedic Health Hazards in Cardiac Catheterization Laboratories are ‘Unacceptable’
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A survey conducted by the Society for Cardiovascular Angiography and Interventions (SCAI) highlights ongoing radiation and orthopedic hazards faced by interventional cardiologists and cardiac catheterization laboratory (“cath lab” or CCL)...
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A survey conducted by the...
03/05/2025
Cath Lab Digest
Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD).
IVL
Shockwave Medical Launches Novel Forward Intravascular Lithotripsy Platform in U.S. to Transform Treatment of Difficult-to-Cross Calcified Lesions
03/04/2025
Now available in the U.S., the Shockwave Javelin Peripheral Intravascular Lithotripsy Catheter safely modifies and crosses occlusive or extremely narrowed calcific peripheral artery disease.
Now available in the U.S., the Shockwave Javelin Peripheral Intravascular Lithotripsy Catheter safely modifies and crosses occlusive or extremely narrowed calcific peripheral artery disease.
Now available in the U.S., the...
03/04/2025
Cath Lab Digest
Acute Ischemic Stroke
FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
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Genentech announced that the U.S. FDA has approved TNKase® (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.
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Genentech announced that the...
03/03/2025
Vascular Disease Management
TEVAR
Zenith Alpha Thoracic 2 Now Available in US; First Case Performed
03/03/2025
Cook Medical’s Zenith Alpha® 2 Thoracic Endovascular Graft (ZTA2) is now commercially available throughout the United States.
Cook Medical’s Zenith Alpha® 2 Thoracic Endovascular Graft (ZTA2) is now commercially available throughout the United States.
Cook Medical’s Zenith Alpha® 2...
03/03/2025
Vascular Disease Management

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