News | Left Atrial Appendage (LAA) Occluders | September 02, 2016

St. Jude Medical Launches Amplatzer Amulet LAA Occluder Trial

IDE trial will expand access to the left atrial appendage occluder device to patients in the United States who are in need of LAA closure to reduce their risk of stroke

St. Jude Medical, Amplatzer Amulet LAA occluder, left atrial appendage, IDE trial

September 2, 2016 — St. Jude Medical Inc. announced the start of the St. Jude Medical Amplatzer Amulet IDE trial of the company’s Amplatzer Amulet Left Atrial Appendage (LAA) Occluder. The trial will evaluate the safety and effectiveness of the device, used to close the LAA in patients diagnosed with non-valvular atrial fibrillation (AF). The first implant of the study took place at North Mississippi Medical Center in Tupelo, Miss., by Jim Stone, M.D.

In most people, the LAA — a small appendage connected to the left atrium — does not increase the risk of adverse health effects, but in some patients with atrial fibrillation, the LAA does not contract effectively and it can become a source of blood clots. These clots can then be released into the heart and enter the bloodstream, where they can travel to the brain and cause a stroke. Currently, patients with AF at risk of stroke are often prescribed blood-thinning medication, but this treatment approach comes with a lifetime of medical management and the risk of major bleeding. By closing the LAA with the Amplatzer Amulet occluder, physicians can “seal off” the LAA and potentially reduce the risk of stroke.

The device works by blocking the LAA at its opening, which minimizes the opportunity for blood clots to form in the LAA and migrate into the bloodstream. The Amplatzer Amulet occluder, the second-generation St. Jude Medical LAA occlusion device, is built with a longer lobe and waist than the previous version and designed to allow for easier and more stable placement, which could result in shorter procedure times for patients. The device is also offered in eight sizes to accommodate varying anatomies.

“There’s a real need within the United States medical community for a left atrial appendage occluder that addresses a wider range of complex patient anatomies,” said Dhanunjaya Lakkireddy, M.D., professor of medicine and the director of the Center for Excellence in Atrial Fibrillation and Complex Arrhythmias at the University of Kansas. “The Amulet device has been used successfully in Europe, and I see this IDE trial as the right step toward providing patients with atrial fibrillation the optimal level of care to further reduce the risk of stroke.”

The AMPLATZER Amulet IDE trial is a randomized trial, which will enroll patients at up to 100 sites in the United States and an additional 50 sites internationally. Patients enrolled in the AMPLATZER Amulet IDE trial will be randomly assigned to receive either the St. Jude Medical Amulet device or a U.S. Food and Drug Administration (FDA)-approved LAA closure device in the control arm of the study. Data collected across all trial sites will be used to support FDA approval of the Amplatzer Amulet Occluder.

The Amplatzer Amulet Left Atrial Appendage Occluder is CE Mark approved and available in Europe.

For more information: www.sjm.com

Related Content

Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Recent Acquisitions Eroding Prices in Billion Dollar European Interventional Cardiology cath lab Market.
Feature | Cath Lab | May 07, 2018 | Simon Trinh and Jeffrey Wong
The European interventional cardiology market is currently valued at nearly $1.4 billion.
Videos | Cath Lab | May 07, 2018
Imran Ahmad, M.D., medical director of interventional cardiology, explains some of the new technologies his labs have
360 Photos | Cath Lab | April 20, 2018
A 360 degree view of the newest cath lab at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., located
SCAI Announces Global Lecture Series for 2018 Scientific Sessions
News | Cath Lab | April 18, 2018
Many of the world’s leading interventional cardiologists and cardiovascular professionals will convene in San Diego,...
Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Figure 1. Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Feature | Cath Lab | April 16, 2018 | Azeem Latib, M.D.
Over the last decade, there have been considerable developments in procedural techniques and technology facilitating
Overlay Init