News | October 29, 2010

LAA Occluder System CE Mark Study Launched


The first-in-man use of the Coherex WaveCrest left atrial appendage (LAA) occluder system was successfully performed recently in New Zealand, launching the WAVECREST 1 trial to evaluate the device's effectiveness. The trial is being carried out in New Zealand, Australia and several European countries and will be used to seek CE mark approval for the device.

The first procedure was performed at Auckland City Hospital in New Zealand by Peter Ruygrok, M.D.

“The Coherex WaveCrest system is a significant advance in LAA occlusion technology,” Ruygrok said. “It offers several major advantages over early LAA devices. It enabled us to optimize the placement of the implant and to seal off the LAA, while minimizing the risk of complications during and after the procedure. The first implantation of this device was extremely successful. WaveCrest presents a valuable new treatment option for patients who suffer from atrial fibrillation and the associated risks of stroke, and possibly enables patients to discontinue difficult-to-manage blood thinners such as Coumadin. This particular patient was at high risk for recurrent stroke, and the structure of the LAA was quite complicated. Nevertheless, the Coherex WaveCrest performed beautifully and our patient is doing quite well.”

Coherex Medical is currently in discussions with the U.S. Food and Drug Administration (FDA) regarding the design of a pivotal trial that may lead to U.S. clearance for the Coherex WaveCrest. The company expects to begin the FDA trial sometime in late 2011.

The LAA is a small pouch-like structure found in every human heart and known as a potential breeding ground for blood clots in patients with atrial fibrillation. It is believed to cause 15 percent of all strokes.

For more information: www.coherex.com


Related Content

News | Cardiovascular Clinical Studies

Nov. 10, 2025 —Genomics, a science-led techbio company, has today announced new research that suggests polygenic risk ...

Home November 12, 2025
Home
News | Cardiovascular Clinical Studies

Oct. 21, 2025 – AskBio Inc., a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG ...

Home October 21, 2025
Home
News | Cardiovascular Clinical Studies

Aug. 25, 2025 — Merck, known as MSD outside of the United States and Canada, has announced that new clinical trial and ...

Home August 25, 2025
Home
News | Cardiovascular Clinical Studies

Aug. 18, 2025 — (Newswise) It’s often mistaken for a heart attack, but Takotsubo cardiomyopathy — previously known as ...

Home August 21, 2025
Home
News | Cardiovascular Clinical Studies

Aug. 20, 2025 — A major international study published in Atherosclerosis* has found that routinely testing for ...

Home August 20, 2025
Home
News | Cardiovascular Clinical Studies

Aug. 4, 2025 — Marea Therapeutics, Inc., a clinical-stage biotechnology company that develops next-generation medicines ...

Home August 04, 2025
Home
News | Cardiovascular Clinical Studies

July 16, 2025 — Medtronic has announced that the first patient has been enrolled in the PEripheral Onyx Liquid Embolic ...

Home July 22, 2025
Home
News | Cardiovascular Clinical Studies

June 11, 2025 — Bayer and the Broad Institute have have extended their research collaboration of 10 years by an ...

Home June 11, 2025
Home
News | Cardiovascular Clinical Studies

May 27, 2025 — Despite scientific advances in cardiovascular care, people in living in rural areas and other communities ...

Home May 27, 2025
Home
News | Cardiovascular Clinical Studies

May 20, 2025 — Shockwave Medical, Inc., part of Johnson & Johnson MedTechhas announced the 30-day primary endpoint ...

Home May 21, 2025
Home
Subscribe Now