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Regulatory Process Begins for Stenting Platform for Bifurcation Lesions
Advanced Bifurcation Systems announced that it has filed a pre-submission with the FDA to define its clinical pathway leading to a PMA for its new bifurcation stenting platform designed to reduce the need for open-heart surgery and standardize treatment of all bifurcation lesions in coronary angioplasties. The company is also defining its regulatory and clinical strategy to obtain a CE Mark for the technology, according to a company press release.
The Advanced Bifurcation Systems patented bifurcation stenting platform addresses main and side branches in four steps and uses bifurcating stents deployed on a Mother/Daughter monorail to branch and self-align covering bifurcations with no gaps and utilizes a dual-catheter system to move stents into position in one continuous process. The platform eliminates gaps or overlaps and tangling of wires associated with current stent installations, CEO Charles Laverty and Chief Medical Officer Mehran Khorsandi, MD, interventional cardiologist and member of the HARTS stent team at Cedars-Sinai Medical Center, told Cardiology Today’s Intervention.
Edwards Lifesciences Announces New Study of Self-expanding Transcatheter Heart Valve
Edwards Lifesciences has commenced a U.S. pivotal trial to study the self-expanding Centera transcatheter valve for severe, symptomatic aortic stenosis patients at intermediate risk for open-heart surgery.
The prospective, single-arm, multicenter study is expected to enroll approximately 1,000 patients and includes a bicuspid registry. The study has a composite endpoint of all-cause death and/or all stroke at 1 year. The Edwards Centera valve is delivered via a low-profile, 14F, motorized delivery system. It is packaged with the valve fully pre-attached to the delivery system to facilitate simple and rapid device preparation. The Centera valve was approved in Europe in February 2018 for the treatment of high-risk patients with severe, symptomatic aortic stenosis. The Centera valve is not currently approved for commercial sale in the United States.
Enrollment Progressing in Studies of Venous Access System
Bluegrass Vascular Technologies announced that it completed enrollment of a European postmarket registry for its system to facilitate access in venous occlusions.
The company also announced that it has expanded enrollment of SAVE-US, the Investigational Device Exemption study of the system in the United States, and added patient sites.
The system (Surfacer) is designed for use in procedures on patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods, according to the company. It received a CE mark in 2016 but is not yet approved for use in the U.S.
Imaging Suite Developed for Minimally Invasive Structural Heart Procedures
Canon Medical Systems announced that it has unveiled a suite of imaging solutions for structural heart interventions.
According to a press release from the company, the suite includes rapid CT imaging technologies (Aquilion One/Genesis and Aquilion Prime SP) to assist in planning of complex structural heart procedures, solutions to enhance the speed and precision of angiography procedures used in valve replacement (Infinix-i) and an ultrasound technology (Aplio i900) that can deliver fast mitral valve analysis during planning, implantation and postoperative evaluation.
“As a physician, I am always looking for innovative techniques including transcatheter therapies like TAVR, MitraClip and left atrial appendage exclusion to treat complex diseases that are safer for my patients,” Peter Fail, MD, director of cardiac catheterization laboratories and interventional research, Terrebonne General Medical Center, Houma, Louisiana, said in the release. “Advanced diagnostic imaging technology can play a critical role in successfully completing TAVR procedures, which is less invasive than open-heart surgery.”
Money Raised to Support IDE Trial of Sirolimus-coated Balloon
To support an Investigational Device Exemption trial for a sirolimus-coated balloon for use in peripheral and coronary procedures, Concept Medical Inc. has raised $60 million.
The company announced that the funds were raised from cardiologist and entrepreneur Kiran Patel, MD, and that it has approached the FDA about getting approval to commence an IDE trial.
In addition to supporting the trial, the funds will also be used to augment clinical data and registries to qualify for reimbursement in European markets and to bolster manufacturing operations, the company stated in a press release.
The balloon (MagicTouch-DEB) is available in several countries around the world, but not yet in the U.S.
Editor’s Note: This is a new column that will offer updates about device and pharmaceutical products and technologies that may be of interest to the interventional cardiology community.