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Abiomed Receives FDA Approval to Conduct MINI-AMI Study With Impella 2.5

December 2, 2010—Abiomed, Inc. (Danvers, MA) announced that it has received conditional approval from the US Food and Drug Administration to begin MINI-AMI, a prospective, randomized, controlled multicenter trial to assess the potential role of the company's Impella 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI).

Roxwood Medical Conducts Full Launch of MicroCross Catheter in United States

December 14, 2015—Roxwood Medical Inc. announced the commencement of the full launch of the MicroCross catheter for use in the coronary and peripheral vasculatures in the United States. The device, which is offered in two sizes, Micro14 and Micro18, is designed to provide enhanced guidewire support through challenging and tortuous anatomy.

Phase 2 of REFLECT Trial Begins for Keystone Heart's TriGuard 3 Embolic Protection Device

June 18, 2018—Keystone Heart Ltd. recently announced the launch of phase 2 of the REFLECT trial to evaluate the safety and efficacy of the company's next-generation TriGuard 3 cerebral embolic protection device for use during transcatheter aortic valve replacement (TAVR).

Keystone Heart Accelerates Trials for Next-Generation TriGuard 3 Cerebral Embolic Protection Device

August 7, 2017—Keystone Heart Ltd. recently announced plans to initiate clinical trials for a new version of the company's TriGuard 3 cerebral embolic protection device, a third-generation device that incorporates technological improvements over earlier versions.

Pivotal REFLECT Study Begins for Keystone Heart's TriGuard Embolic Deflection Device

June 17, 2016—Keystone Heart Ltd. announced enrollment of the first patient in the pivotal United States REFLECT study to evaluate the safety and efficacy of the company’s TriGuard embolic deflection device.

Extended Access Registry for Tryton Side Branch Stent Begins Enrollment

September 10, 2014—Tryton Medical, Inc. announced that Jeffrey W. Moses, MD, enrolled the first patient in the United States in the Extended Access Registry, a single-arm study of the Tryton side branch stent that is expected to enroll 133 patients from Europe and the United States. Dr. Moses is Director of Cardiovascular Interventions at New York Presbyterian Hospital/Columbia University Medical Center and Professor of Medicine at the Columbia University College of Physicians and Surgeons.

PROTECT III Evaluates Abiomed’s Impella Placement Before High-Risk PCI

May 19, 2020—Abiomed announced that data from more than 1,000 patients demonstrated that the company’s Impella device reduces in-hospital mortality when placed before a nonemergent percutaneous coronary intervention (PCI) is performed.

REFLECT II Trial Evaluates Keystone Heart's TriGuard 3 Cerebral Deflection Filter for TAVR

October 15, 2020—The REFLECT II randomized clinical trial evaluating the safety and efficacy of the TriGuard 3 self-stabilizing cerebral embolic deflection filter (Keystone Heart, Ltd., a Venus Medtech company) found that the device met the primary safety endpoint compared to historical controls but did not demonstrate superiority of the device for the primary hierarchical efficacy endpoint.

Abiomed Launches CAMP PCI Virtual Physician Education Program

June 16, 2020—Abiomed announced the launch of the Coronary Artery & Myocardial Protected Percutaneous Coronary Intervention (CAMP PCI) digital education platform.

Abiomed Impella CP Receives Expanded FDA Approval for High-Risk PCI Procedures

December 7, 2016—Abiomed, Inc. announced it has received expanded US Food and Drug Administration (FDA) premarket approval for Impella heart pump use in high-risk percutaneous coronary interventions (PCI) to include the Impella CP treatment option with the ability to stabilize the patient's hemodynamics and unload the left ventricle of the heart, which allows the muscle to rest and recover its native function.

Interim Analysis Presented From PROTECT III Study of Abiomed’s Impella Device in High-Risk PCI Patients

October 15, 2020—Abiomed announced that new data from an interim analysis of the PROTECT III study demonstrate reduced rates of major adverse cardiac and cerebrovascular events (MACCEs; a composite of death, stroke, myocardial infarction, and repeat procedures) when the company’s Impella device is used to achieve more complete revascularization in a single setting for high-risk percutaneous coronary intervention (PCI) patients.

Data Published on Corindus CorPath 200 Robotic PCI System

April 15, 2011—Findings from a first-in-human study that aimed to evaluate the safety and feasibility of the CorPath 200 remote-controlled, robotic angioplasty system (Corindus, Inc., Natick, MA) in the delivery and manipulation of coronary guidewires, balloons, and stents in patients undergoing elective percutaneous coronary intervention (PCI) were published by Juan F. Granada, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2011;4:460–465).