Dave Fornell, Editor DAIC
At the beginning of each year, I always try to determine what the next big cardiovascular technology advances to watch will be in the coming 12 months. I did not have to look far, as the U.S. Food and Drug Administration (FDA) has pretty much outlined four of these advances with recent meeting notices and approval of a new clinical trial.
TAVR in Low-Risk Patients
In January, the FDA gave its blessing to start the PARTNER III Trial, which will be the first to examine using transcatheter aortic valve placement (TAVR) in low-risk surgical patients. The trial is another step toward making TAVR available to all patients and eliminating the need for open-heart valve replacement surgery. The expanded indication study is for the Edwards Sapien 3 valve in patients age 65 or older with severe aortic stenosis. The 1,300 patient study will enroll at up to 50 sites is expected to begin during the second quarter of 2016. Read more on the Partner III Trial.
The First Bioresorbable Stent
The FDA’s Circulatory System Devices Panel will meet March 15 to review data and offer recommendations concerning the final approval of Abbott’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System to treat coronary lesions. This is the first fully bioresorbable stent to come before the FDA and a final decision on its market clearance is expected later this year.
Results from the ABSORB II pivotal FDA clinical trial showed the everolimus-eluting stent was non-inferior after one year compared to Abbott's Xience V, the best current generation metallic drug-eluting stent on the market. Findings from the ABSORB III trial were presented as one of the key late-breaking studies at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium last fall.
Cardiology experts believe drug-eluting bioresorbable stents may replace the current gold standard of drug-eluting metallic stents in the coming years. The new devices eliminate the use of permanent implants and clinical evidence indicates treated vessels return to normal function after the stent dissolves, allowing vasodilation and vasoconstriction.
(Update July 5, 2016 — FDA Approves First Totally Bioresorbable Stent)
Heart Attack Monitor
The Circulatory System Devices Panel will also review the final PMA application for the first implantable heart attack monitor March 16. The AngelMed Guardian System is intended to alert patients to ST segment shifts in their ECGs that indicate coronary ischemia. For patients with prior acute coronary syndrome events who are at risk for recurrent heart attacks, the system is designed to reduce the symptom-to-door times. These times are currently about two to three hours, and the longer it takes to revacularize the blockages, the poorer the patient outcomes. The system serves as an early warning system, alerting patients that they need to seek immediately medical attention.
The Circulatory System Devices Panel will also convene Feb. 18 to gather public recommendations on clinical trials, post-approval study design and physician training requirements for leadless cardiac pacemakers. The panel will then help guide FDA policy for this new class of electrophysiology devices. Recommendations will include the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles.
The FDA is anticipating review of several leadless pacemakers in the near future. These devices are about the size of a large vitamin and are implanted using minimally invasive transcatheter implantation directly inside the heart. The first two devices expected to come before the FDA are the Medtronic Micra and the St. Jude Medical Nanostim.
Primary results from the Nanostim LEADLESS II study were presented at presented as a Hotline session at the European Society of Cardiology (ESC) Congress 2015. Data show the leadless pacemaker’s retrieval of the implanted device was successful in 100 percent of patients requiring retrieval without any associated complications. The device’s battery could be projected to last an average of 15 years, and possibly projected as high as 21 years depending on pacing needs. Adverse events were comparable to conventional pacemakers, St. Jude said.
Data from the Micra TPS Global Clinical Trial were presented as a late-breaking special report at the 2015 American Heart Association (AHA) Scientific Sessions. Results showed 96 percent of patients experienced no major complications, which is 51 percent fewer major complications than seen in patients with conventional pacing systems. Also, no device dislodgements or systemic infections were reported, and the need for system revisions was less than 1 percent. Micra received European market approval in April 2015.
Read the article "7 Transformative Medical Technologies to Watch in 2017 and Beyond"