A Medical Device Daily
Edwards Lifesciences (Irvine, California) has reported the launch of the company's transfemoral delivery system for the Edwards Sapien transcatheter heart valve at EuroPCR 2008 in Barcelona, Spain.
The RetroFlex II delivery system retains many of the features of the RetroFlex delivery system, and adds a tapered nose cone that facilitates the passage of the valve delivery catheter over the curve of the aortic arch and through the patient's native, diseased aortic heart valve. The new delivery system is designed to enhance ease-of-use and improve access during the transcatheter aortic valve replacement procedure. European centers will benefit from this new technology during the coming weeks.
"At EuroPCR, we will share clinicians' experiences and insights into achieving a high rate of acute procedural success with the Edwards Sapien transcatheter valve, providing other clinical centers with the opportunity to learn from the current experience," said Patrick Verguet, Edwards' corporate VP, Europe. "With more than 1,000 transcatheter heart valve patients worldwide, we look forward to continuing to work closely with clinicians in Europe and offering this technology to more patients."
The first procedures with the new transfemoral delivery system were performed by John Webb, MD, director of the cath lab and cardiac intervention at St. Paul's Hospital (Vancouver, British Columbia). His multidisciplinary team has performed more than 150 transcatheter aortic valve replacement procedures, including more than 25 using the RetroFlex II delivery system.
"The RetroFlex II delivery system is a big step forward. It is designed to give the physician maximum control when delivering and implanting the transcatheter aortic valve, making it easier to get to and then cross the patient's native valve," said Webb.
The company this week also will be providing an update on the Monarc feasibility study. One-year follow-up data from the EVOLUTION feasibility study of Edwards' Monarc system will be provided at EuroPCR by Jan Harnek, MD, PhD, director of the cardiac catheterization lab at Lund University Hospital (Sweden).
"We are encouraged by the early signs of efficacy from the EVOLUTION feasibility study of the Monarc system, which was conducted in Europe and Canada," said Stanton Rowe, Edwards' corporate vice president, advanced technology. "Working in close cooperation with our physician partners, we are committed to moving forward to the phase two study, EVOLUTION II, which will include tracking the clinical outcomes of the participating heart failure patients and ultimately establishing a new therapeutic option. We look forward to providing additional details about the design of EVOLUTION II at scientific conferences later in the year."
In other news from the conference: PLC Systems (Franklin, Massachusetts), a company focused on cardiac and vascular medical device-based technologies, reported that it is demonstrating its RenalGuard System at EuroPCR this week.
RenalGuard is based on existing preclinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.
PLC received the CE Mark Certificate for the RenalGuard System in late December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The company has received conditional approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of RenalGuard in the prevention of CIN.