Search Results

Conformal Medical Presents Early Feasibility Study Results for LAA Assessment

February 27, 2023—Conformal Medical, Inc. announced the presentation of results from the CONFORMAL early feasibility study, which is evaluating the use of angiography compared to transesophageal echocardiogram (TEE) for left atrial appendage (LAA) assessment.

Early Studies Presented for Conformal Medical CLAAS Left Atrial Appendage Closure Technology

October 15, 2020—Conformal Medical, Inc. announced that clinical data from two first-in-human studies of the company's next-generation CLAAS left atrial appendage closure (LAAC) technology were presented in two abstracts by Vivek Reddy, MD, and William Gray, MD, at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.

Conformal’s CLAAS System for LAAO Evaluated at 1-Year in Early Feasibility Study

October 24, 2023—Conformal Medical, Inc. announced 1-year results from the CONFORMAL Early Feasibility Study (EFS) of the company’s CLAAS left atrial appendage occlusion (LAAO) system.

Vivasure Medical PerQseal+ Evaluated in United States Early Feasibility Study for Large-Bore Closure

March 15, 2022—Vivasure Medical, an Ireland-based developer of fully absorbable percutaneous vessel closure technology, announced that the first patient was treated in a United States early feasibility study evaluating the PerQseal+.

Conformal Medical’s CLAAS LAAO Device Evaluated in Published Preclinical Study

January 5, 2023—Conformal Medical, Inc., which is developing next-generation left atrial appendage occlusion (LAAO) technology, announced the publication of a preclinical study of the company’s CLAAS LAAO device in a healthy canine model.

Vivasure Commences Pivotal PATCH Study of PerQseal Closure Device System

May 2, 2023—Vivasure Medical, an Ireland-based company developing fully absorbable technology for percutaneous vessel closure, announced it has commenced the company’s PATCH pivotal study, which is evaluating the safety and efficacy of the Vivasure PerQseal closure device system.

SKYWARD Pivotal Studies of Shockwave SkyRunner Carotid IVL Platform Begin Enrollment

June 25, 2026—Johnson & Johnson announced the initiation of its SKYWARD investigational device exemption (IDE) clinical program evaluating the company’s Shockwave SkyRunner carotid intravascular lithotripsy (IVL) system for the treatment of calcified carotid arteries when used before stenting with a commercially available transcarotid or transfemoral stent system.

Conformal CLAAS System’s Thrombogenicity Evaluated in Comparative Study

March 19, 2024—Conformal Medical, Inc. recently announced that findings from an in vitro study comparing the relative thrombogenicity of the company’s CLAAS left atrial appendage occlusion (LAAO) implant to the Watchman FLX device (Boston Scientific).

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.

Conformal Medical’s CLAAS LAAO Device Begins CONFORM Pivotal Trial

June 17, 2022—Conformal Medical, Inc. announced the launch of the CONFORM pivotal trial that will evaluate the safety and efficacy of the company’s CLAAS left atrial appendage occlusion (LAAO) system compared to commercially available LAAO devices.

Three-Year Neuroguard IEP PERFORMANCE II Data Presented

March 13, 2026—Three-year outcomes from the PERFORMANCE II trial studying the Neuroguard Integrated Embolic Protection (IEP) 3-in-1 Carotid Stent System were presented by William A. Gray, MD, at the International Symposium on Endovascular Therapy (ISET).

Baylis Medical's All-in-One VersaCross Transseptal Solution Used in MitraClip Procedure

September 23, 2019—Baylis Medical Company, Inc. announced the first MitraClip procedure performed using the company’s VersaCross transseptal solution.

Radiaction Establishes Medical Advisory Board

August 13, 2024—Radiaction Medical, Ltd, an Israel-based medical device company founded by Amir Belson, MD, announced the formation of its United States medical advisory board (MAB).

Vivasure’s PerQseal Closure Device Evaluated in Initial Results From PATCH Pivotal Study

November 3, 2024—Vivasure Medical recently announced initial positive results from its PATCH pivotal study conducted in the United States under an investigational device exemption, evaluating the safety and efficacy of the Vivasure PerQseal closure device system.