Search Results

InspireMD Announces PIs for C-GUARDIANS II Trial Evaluating the SwitchGuard Neuroprotection System

February 12, 2024—InspireMD, Inc. named Patrick Geraghty, MD, and Patrick Muck, MD, as the lead Principal Investigators (PIs) for the company’s upcoming C-GUARDIANS II clinical trial for the SwitchGuard neuroprotection system (NPS).  According to the company, the C-GUARDIANS II study will aim to advance clearance of SwitchGuard NPS and associated tools, which are designed to allow the treating physician to reverse cerebral blood flow during a transcarotid artery revascularization procedure, preventing embolic debris generated during the procedure from traveling to the brain by passing the blood through the filter enclosed within the SwitchGuard before returning it to the patient to minimize blood loss.

Safety and Efficacy Data Presented for BD's Lutonix DCB in Below-the-Knee Arteries

May 1, 2019—Patrick Geraghty, MD, presented 6-month results from the Lutonix BTK trial at the 2019 Charing Cross Symposium, held April 15–18 in London, United Kingdom.

One-Year TOBA II BTK Data Presented for Intact Vascular's Tack Endovascular System (4F)

June 25, 2020—Intact Vascular, Inc. announced that 1-year results from the Tack Optimized Balloon Angioplasty II Below-the-Knee (TOBA II BTK) clinical trial were presented online by coprincipal investigator Patrick Geraghty, MD, during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial livestream.

InspireMD Earns IDE Approval for CGUARDIANS II Pivotal Study

October 7, 2024—InspireMD, Inc., developer of the CGuard embolic prevention stent system for the prevention of stroke, announced that the FDA has approved the company’s application for an investigational device exemption (IDE) to initiate the CGUARDIANS II pivotal study of the company’s CGuard Prime 80-cm carotid stent system during TCAR (transcarotid artery revascularization) procedures.

IDE Approved for Pivotal Study of InspireMD’s SwitchGuard Neuro Protection System

May 14, 2026—InspireMD, Inc., developer of the CGuard Prime carotid stent system for the prevention of stroke, announced that the FDA has approved the company’s investigational device exemption (IDE) application to initiate the CGUARDIANS III pivotal study.

FDA Approves Intact Vascular's Tack Endovascular System for BTK Dissection Repair

April 14, 2020—Intact Vascular, Inc. announced FDA approval of its Tack (4-F) endovascular system for repair of postangioplasty dissections in the mid/distal popliteal, tibial, and/or peroneal below-the-knee (BTK) arteries ranging in diameter from 1.5 to 4.5 mm.

Bard Begins Enrollment in Lutonix BTK Clinical Trial

June 4, 2013—Bard Peripheral Vascular (Tempe, AZ) announced commencement of enrollment in the Lutonix below-the-knee (BTK) clinical trial.

Interim 1-Year VIBRANT Results Presented for Gore Viabahn in SFA Treatment

October 22, 2009—In the late-breaking trials session at the Vascular Interventional Advances meeting in Las Vegas, Nevada, Gary M. Ansel, MD, presented 1-year interim results from the VIBRANT (Viabahn Versus Bare-Nitinol Stent) study of the Gore Viabahn endoprosthesis (WL Gore & Associates, Inc., Flagstaff, AZ) in the treatment of long-lesion (≥ 8 cm) superficial femoral artery (SFA) occlusive disease.

Intact Vascular Completes Enrollment for TOBA II BTK Trial

January 3, 2019—Intact Vascular, Inc. announced that it has completed enrollment ahead of schedule for its TOBA II BTK clinical trial.

Six-Month Data From Intact Vascular TOBA II BTK Trial Presented

November 6, 2019—Intact Vascular, Inc. announced that the 6-month results of its Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial achieved all primary (P < .0001) and secondary endpoints with very low rates of major amputation and all-cause death.

Cook Announces FORMAT Study of Formula Iliac Stent

July 29, 2013—Cook Medical (Bloomington, IN) announced that it is conducting a study of an investigational stent as a potential treatment for peripheral arterial disease.