News | Embolic Protection Devices | September 07, 2017

Protembis Announces Successful First-in-Human Use of ProtEmbo Cerebral Protection System in European Trial

Intra-aortic filter device designed to cover all three aortic side branches to deflect embolic material from the brain during TAVR

Protembis Announces Successful First-in-Human Use of  ProtEmbo Cerebral Protection System in European Trial

September 7, 2017 — Protembis GmbH announced the first clinical applications of its ProtEmbo Cerebral Protection System to complement a transcatheter aortic valve replacement (TAVR) procedure. The ProtEmbo System is an intra-aortic filter device that deflects embolic material arising during TAVR away from the brain.

Darren Mylotte, M.D., and his team at Galway University Hospital, Ireland, performed the first-in-human procedure with the ProtEmbo System. He commented: “Over the next 10 years, TAVR procedures are expected to increase fourfold. With TAVR shifting to younger and lower-risk patients, cerebral protection becomes even more important. Clinical data from two recent studies of intermediate-risk patients undergoing TAVR suggest 30-day stroke risk as high as 5.5 percent. It is therefore critically important that we have a cerebral-focused protection device that will reduce the frequency of embolic events. The ProtEmbo System shows tremendous promise in reaching this clinical objective – first-in-human use of the device was safe and feasible.”

The objective of the current ongoing European trial is to demonstrate the safety and feasibility of the ProtEmbo System when used to provide embolic protection during TAVR. It was successfully deployed via the left radial artery across all three branches of the aortic arch for the duration of the TAVR procedures. The procedures were conducted under conscious sedation. On completion of the valve implant, the system was safely withdrawn without difficulty. None of the patients experienced a stroke event and there were no other device-related adverse events.

Features and benefits of the ProtEmbo include:

  • Low-profile access via left radial artery (6Fr guiding sheath);
  • Best access route: no interference with TAVR catheter or accessories;
  • Simple, quick and reliable deployment;
  • Complete coverage of all three aortic side branches;
  • Deflection of microparticles, as tiny as 60 microns;
  • Suitable for a wide variety of aortic arch anatomies; and
  • Heparin coating for optimal biocompatibility.

Renu Virmani, M.D., president and medical director at CVPath Institute, Gaithersburg, Md., commented: “Our preclinical work with the ProtEmbo System prior to this clinical trial resulted in no safety or biocompatibility concerns. These initial findings from Europe now confirm our previous results. Despite the small pore size of the ProtEmbo System, there is no thrombus formation on the filter. This is promising because it may enable physicians to deflect even smaller particles away from the brain.”

Watch a video animation showing how the ProtEmbo system is deployed.

For more information: www.protembis.com

Related Content

Montreal Heart Institute Performs First Robotic Mitral Valve Surgery
News | Robotic Systems| September 22, 2017
The Montreal Heart Institute (MHI) announced the acquisition of the da Vinci Xi, a new-generation surgical robot, and...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Overlay Init