2015 MedDeviceTracker Post-TCT Report

November 13, 2015

This report highlights notable trial data released at this year's 2015 Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting that took place October 10-15 in San Francisco, CA. Coronary stents had the most new salient data at this year's TCT, especially first data from the ABSORB III IDE trial. Updated data for transcatheter aortic valve replacement (TAVR/TAVI) was more incremental, though 1 year data from Sapien 3's IDE trial was also important. Peripheral drug- eluting balloons showed signs of persistent efficacy in their second year, and HeartMate PHP, a potential competitor for Impella, had interesting, albeit preliminary first data. <b>The report includes coverage on the following topics:</b> <ul> <li>Coronary Stents and Balloons</li> <ul style="font-size: 11px;"> <li>In first data from the ABSORB III IDE trial, the Absorb (ABT) bioresorbable scaffold achieved non-inferiority with Xience on the primary endpoint, target lesion failure (TLF) at 1 year. However, a higher numerical rate on TLF and a trend for more stent thrombosis raises questions, though operator experience could contribute.</li> <li>The Dreams (Biotronik) absorbable metal scaffold encouragingly showed an improvement in late lumen loss (LLL) and other measures in BIOSOLVE-II, compared to the problematic first-generation stent.</li> <li>In the LEADERS FREE EU trial of patients at high risk of bleeding, the BioFreedom polymer free umirolimus-coated stent encouragingly showed superiority on target lesion revascularization and MACE compared to a bare metal stent.</li> <li>Preliminary OCT data for MDT's polymer free Drug-filled Stent</li> </ul> </br> <li>Transcatheter Valve Replacement (TAVR/TAVI)</li> <ul style="font-size: 11px;"> <li>One-year data from the Sapien 3 IDE trial showed a higher mortality rate than the recently reported CE Mark study, but that could be due to higher risk patients. It is difficult to say whether the valve has a clinical advantage over other new generation valves, though the disabling stroke rate was lower than what has been seen in competitor studies.</li> <li>A study on reduced leaflet mobility published in the NEJM just before the conference suggested the cause was leaflet thrombosis that could be prevented or treated with anticoagulation.</li> <li>Data from the Sentinel (Claret) cerebral protection system's MISTRAL-C trial had signs suggesting a neurocognitive benefit versus no protection, while reducing MRI lesion volume and increasing the number of patients without any lesions.</li> </ul> </br> <li>Peripheral Drug-Eluting Baloons (DEB)</li> <ul style="font-size: 11px;"> <li>Lutonix (BCR) and IN.PACT Admiral (MDT) both encouragingly had 2 year data suggesting durable effects based on only small changes in target lesion revascularization.</li> </ul> </br> <li>Ventricular Assist Devices</li> <ul style="font-size: 11px;"> <li>Initial data for HeartMate PHP was presented for both the SHIELD I high-risk PCI trial, used to support its CE Mark, and a small initial experience in cardiogenic shock. While there were some encouraging preliminary data, with some signals that support could be better than Impella 2.5, these were only preliminary single-arm studies and there is some question about cases of new/worsening aortic insufficiency.</li> </ul> </ul> </br> To download a complimentary copy of MedDeviceTracker's <b>2015 Post-TCT Report</b>, please use the form to the right. </br> </br> <font size=1>For our disclosures, please read the <a href="Standards.cfm" target="_blank">BioMedTracker Research Standards</a>.</font>