News | Heart Valve Technology | September 19, 2016

Boston Scientific Gains European Approval for Next Generation Lotus Edge TAVR System

System has a feature to help reduce need for pacemakers

Lotus Edge Valve, CE mark, boston scientific, TAVR, TAVI

The Lotus Edge system in its deployed position. The Lotus valve expands outward as it is compressed and buckled in the deployment position. It also has a skirt to help eliminate paravalvular leaks.

Lotus Edge Valve, CE mark, boston scientific, TAVR, TAVI

The Lotus Edge deployment catheter.

September 19, 2016 — Boston Scientific received European CE mark approval for its Lotus Edge Valve System, the company's next generation transcatheter aortic valve replacement (TAVR) technology. The Lotus Edge valve system is indicated for aortic valve replacement in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement. Instead of open heart surgery, the replacement valve is delivered via transcatheter percutaneous delivery, a minimally invasive procedure involving a small incision to gain access to a blood vessel.

 
In comparison to the Lotus Valve System, this next iteration incorporates a more flexible, lower profile catheter designed to improve ease of use and accommodate tortuous anatomy. Another differentiating feature of the Lotus Edge valve system is the inclusion of Depth Guard, a design element intended to reduce the need for a permanent pacemaker (PPM). 
 
"The Lotus Edge device is a highly anticipated next generation of the Lotus Valve System," said Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia. "It retains many of its predecessor's unique and valuable proprietary features, including the ability to reposition the device precisely and prevent paravalvular leak, while incorporating new design characteristics such as a more flexible catheter for easier delivery and Depth Guard technology designed to reduce valve interaction with the conduction system of the heart during valve deployment."
 
Leveraging the current Lotus platform, the Lotus Edge valve system integrates the Adaptive Seal technology which minimizes paravalvular leak regurgitation or PVL, as demonstrated in the 1,000 patient RESPOND Post-Market Registry. This study found that 91.9 percent of patients had core-lab adjudicated trace or no PVL pre-discharge, and 7.7 percent had mild PVL. No patients had severe PVL and only 0.3 percent of patients had moderate PVL. Lotus Edge continues to be the only TAVR device that offers controlled mechanical expansion, which allows the valve to be fully deployed and assessed and then repositioned or fully retrieved by the physician, if needed.

Read the article “Boston Scientific Lotus Valve System Demonstrates Extremely Low PVL Rates.”

The Lotus Edge valve system will be available to select centers in Europe, with commercial site expansion accelerating as physicians and centers become fully trained. The Lotus Valve System is an investigational device in the United States and Japan and is not available for sale in those countries.

  

Read the related article, “Advances and Future Directions for Transcatheter Valves.”
 

For more information: www.bostonscientific.com

Related Content

Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major
TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.