News | Heart Valve Technology | January 07, 2019

JC Medical Announces First U.S. Treatment With J-Valve TAVR Device

Catheter-based system designed to provide new option for patients with failing aortic valves

JC Medical Announces First U.S. Treatment With J-Valve TAVR Device

January 7, 2019 — JC Medical announced the successful treatment of the first U.S. patient with the company’s transfemoral transcatheter aortic valve replacement (TAVR) device, the J-Valve TF System. The patient was treated at The Christ Hospital – Cincinnati, Ohio by Dean Kereiakes, M.D., FACC, FSCAI, medical co-director of the Lindner Research Center, working with Joseph Choo, M.D., and Geoffrey Answini, M.D.

The U.S. Food and Drug Administration (FDA) approved the use of the J-Valve for patients with aortic regurgitation through the agency’s expanded access (“compassionate use”) regulatory pathway.

The investigational J-Valve TF system is intended as a new catheter-based option for the treatment of patients who suffer from aortic regurgitation. Failing aortic valves make up a significant portion of patients with heart failure, a major public health problem with a prevalence of more than 1.5 million people in the U.S. and more than 18 million people worldwide. Aortic regurgitation is the primary indication for more than 20 percent of surgical heart valve replacements, but there are no transcatheter aortic valves that are approved in the U.S. or Europe to treat aortic regurgitation patients too sick to undergo open surgical repair.

“The J-Valve TF system has specific attributes that differentiate it from all other currently available TAVR systems, which I believe will enhance the safety and efficacy of TAVR for the indications of aortic valvular insufficiency (regurgitation) and possibly valve-in valve replacement of failing surgically implanted bioprosthetic valves,” said Kereiakes. “J-Valve was clearly the best treatment option for our patient.”

Watch the VIDEO: Key Bioresorbable Stent Technology Presented at TCT 2015, an interview with Kereiakes at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting. 

JC Medical’s J-Valve System is designed to restore normal blood flow out of the heart and into the body, which may improve symptoms of heart failure such as shortness of breath, fatigue and chest pain. The J-Valve features a proprietary anchor mechanism that is flexibly linked to a self-expanding stent frame to attach to the failing native heart valve. The J-Valve does not require calcification of the native valve for fixation.

The world’s first J-Valve TF implant was performed earlier this year by John Webb, M.D., and Jian Ye, M.D., MSc, FRCSC at St. Paul’s Hospital in Vancouver, Canada. This case was recently published online ahead of print in EuroIntervention.1

The company plans to initiate a U.S. clinical trial of the J-Valve in 2019.

For more information: www.j-valve.com

Reference

1. Hensey M., Murdoch D.J., Sathananthan J., et al. First-in-human experience of a new generation transfemoral transcatheter aortic valve for the treatment of severe aortic regurgitation: the J-Valve transfemoral system. EuroIntervention, Nov. 20, 2018. 

Related Content

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.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...
News | Cath Lab | December 18, 2019
December 18, 2019 — Cook Medical initiated a recall of its CrossCath Support Catheters in November, which the U.S.
Gallery | Cath Lab | October 31, 2019 | Dave Fornell, Editor
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
Overlay Init