CDRH Debuts 2017 Experiential Learning Program
The Center for Devices and Radiological Health (CDRH) announced the 2017 Experiential Learning Program (ELP), which allows the center’s staff to visit manufacturing facilities and get a up-close view of the medical device development life cycle.
CDRH is inviting participation from companies, academia, and clinical facilities, medical device incubators and accelerators, health insurers, health technology assessment groups and others, including those that have previously participated in the ELP or other FDA site visit programs.
All sites that participate in the ELP program must have a successful compliance record with the FDA or another agency with which the FDA has a memorandum of understanding.
The submission period for participation in the ELP is March 23 - April 30, 2017. Submissions can be made at www.regulations.gov.
FDA Clears Medtronic’s Transcatheter Valve with Advanced Sealing
Medtronic received FDA clearance for its CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery.
The device is designed with an outer wrap that adds surface area contact between the valve and the native aortic annulus to improve valve sealing.
The device is delivered through the EnVeo R delivery catheter system and is indicated for vessels down to 5.5 mm. The 23mm, 26mm and 29mm sizes of the device are available for use in the U.S.
FDA Grants Clearance to BioStable’s Aortic Annuloplasty Device
BioStable Science & Engineering has received FDA market clearance for its HAART 300 aortic annuloplasty device.
The device is designed to re-size, reshape and stabilize the aortic annulus to restore valve competence and help prevent recurrent aortic regurgitation.
The device received the CE Mark in 2016.
NICE Recommends Boston Scientific Defibrillators
The UK’s National Institute for Health and Care Excellence (NICE) issued guidance recommending the use of Boston Scientific’s cardiac resynchronization therapy defibrillators (CRT-D) for treating patients with heart failure.
The device is designed to extend the battery life of Boston Scientific cardiac resynchronisation therapy-defibrillator CRT-D devices.
CRT-Ds are a treatment option for heart failure and life-threatening ventricular arrhythmias.
Enduralife battery technology uses a lithium manganese dioxide (Li/MnO2) battery chemistry, which is claimed to be less susceptible to the variations in voltage and resistance associated with early battery depletion.
NICE concluded the extended battery life observed with the CRT-D is likely to reduce the number of replacement procedures, offering improved outcomes for patients and saving the National Health Service about £6 million ($7.5 million) in the first five years.