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7 Huge Developments Coming Out of TCT 2019

Here are seven huge takeaways from TCT 2019.

  • There are always big developments coming out of the Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. And this year’s meeting didn’t disappoint. From product approvals to compelling data, here are the seven big takeaways coming from TCT 2019.

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  • BD Gets Some Ink. Published Ink That Is. 

    Becton Dickinson & Co. (BD) did something that would make most companies envious. The Franklin Lakes, N.J.-based company was able to get its company-initiated, independent analysis of the Lutonix 035 Drug-Coated Balloon (DCB) femoropopliteal clinical program published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. These data were simultaneously presented in a late-breaking session at TCT. This independent analysis evaluated Lutonix 035 DCB (N=1093) and standard percutaneous transluminal angioplasty (PTA) (N=250) safety outcomes using patient-level data and propensity-matching from three Lutonix DCB randomized, controlled trials: LEVANT 1, LEVANT 2 and LEVANT Japan, as well as the Continued Access cohort of the LEVANT 2 trial, and confirmed that there was no statistically significant increase in mortality with the use of Lutonix 035 DCB. This is welcomed news for BD, which recently had its application for the approval of the Lutonix drug-coated balloon to treat patients with below-the-knee peripheral artery disease, rejected by FDA.

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  • Medtronic Hits the Ground Running

    At this year's TCT, Medtronic showed companies just how to make an entrance. A few short days before the conference kicked off, the Dublin-based company announced it won a nod from FDA for the Evolut PRO+ TAVR System – a next-generation transcatheter aortic valve replacement system. The company was part of the conversation even before the conversation officially started. And whenever there is a new approval in TAVR, one of the hottest and fastest-growing segments in medtech, rest assured everyone is paying attention.

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  • Abiomed’s Interim Data

    Abiomed came to TCT with data from the PROTECT III trial, an ongoing prospective, single-arm FDA post-market study for the Impella 2.5 and Impella CP in high-risk Percutaneous Heart Intervention (PCI). The Danvers, MA-based company said an interim analysis of 898 patients from the PROTECT III trial demonstrated a reduction in the primary endpoint of death, stroke, myocardial infarction, and repeat procedures at 90 days with Impella-supported Protected PCI. The results extend the hotstreak for Abiomed, which was named one of the 25 most attractive medtech companies on the M&A radar. 

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  • Onyx ONE Global Study Balances Out Medtronic’s TCT Presence

    Sure Medtronic was able to secure approval for a TAVR device ahead of TCT. But what about data? Well, the Dublin-based company delivered with breaking clinical data from the Onyx ONE Global Study. The trial represented the first prospective, multi-center, randomized study evaluating clinical outcomes between two drug-eluting stents (DES) in nearly 2,000 high-bleeding risk (HBR) patients with one month of dual antiplatelet therapy (DAPT). benefit from shorter DAPT regimens. In the study, Medtronic’s Resolute Onyx met its primary composite endpoint of cardiac death, myocardial infarction (MI) or stent thrombosis (ST) at one-year showing non-inferiority vs. the comparator stent, Biosensor’s BioFreedom DCS1 – the only DES discussed by the European Society for Cardiology (ESC) in its guidelines for HBR patients that may need one-month DAPT.

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  • Ancora Heart is That Company to Watch

    Last year Ancora Heart had about one presentation and was still a relatively quiet company. But the story was a little different at TCT 2019. The Santa Clara, CA-based company had a bigger presence and dropped favorable data from the CorCinch FMR study, a U.S. early feasibility study evaluating the safety of the investigational AccuCinch Ventricular Repair System designed for the treatment of systolic heart failure. The private company is a small player in the functional mitral regurgitation space – poised to take on medtech giants Abbott Laboratories and Edwards Lifesciences in the functional mitral regurgitation (FMR) space. If the company can continue to build strong data then it might be one to watch. 

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  • Study Results Help MitraClip Overcome Humble Regulatory Beginnings

    Abbott Laboratories makes the list because of a pair of studies revolving around the MitraClip. New late-breaking data at TCT 2019 demonstrate that Abbott's MitraClip is cost-effective for heart failure patients with significant secondary mitral regurgitation compared to guideline-directed medical therapy alone. In addition, a data analysis demonstrated that over the lifetime of a typical COAPT patient, MitraClip showed improvements in both projected life expectancy and quality of life and that those benefits are sustained through three years. It’s important to point out how significant both these studies are – but to do this one has to go back to 2013 when the device received approval after a series of significant setbacks including a lackluster endorsement from a regulatory panel, mixed study results, and an overseas safety warning. However, times have changed and the device has had strong sales , even recently gaining a nod from FDA for a new indication that addresses the secondary form of mitral regurgitation.

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  • Boston Scientific’s Shares Drop Because of SCOPE 1 RESULTS
    Boston Scientific might have had a shining moment at TCT with its Evolve Short DAPT clinical trial results, but the Marlborough, MA-based company had a less than stellar moment in the SCOPE 1 study. The trial was a head-to-head comparison of Boston Scientific’s Acurate Neo and Edwards Lifesciences’ Sapien 3 Valve. Results show that the Acurate Neo was not noninferior to the Sapien 3. It was a tough blow for Boston Scientific as news of the trial results caused its shares to drop by about 5%.

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