Report Detail
2016 Meddevicetracker Post-TCT Report
Transcatheter Cardiovascular Therapeutics (TCT) is an educational meeting specializing in interventional cardiovascular medicine. The symposium, held this year in Washington, D.C. from October 29 to November 2, 2016, is designed for interventional cardiologists, radiologists, clinical cardiologists, scientists, vascular medicine specialists, cardiac and vascular surgeons, nurse practitioners, cath lab technicians, and other healthcare professionals with a special interest in the field of interventional and vascular medicine.
- Coronary Intervention
Of the presentations in coronary intervention, we have highlighted data on Absorb (Abbott), which received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) in July 2016, as well as other products in development including Amaranth FORTITUDE (Amaranth Medical), Fantom (REVA), DESolve Cx (Elixir), Firesorb (MicroPort), and MeRes 100 (Meril).
Also in the coronary intervention space, we’ve highlighted presentations on currently approved drug-eluting stents such as Abbott’s Xience platform and Boston Scientific’s Promus PREMIER. Additionally, there were presentations on products in development such as Medtronic’s new Drug-Filled Stent and Biotronik’s hybrid Sirolimus-eluting stent, Orsiro.
In addition, St. Jude Medical presented data from its ILUMIEN III Study which is evaluating the benefits of PCI guided by optical coherence tomography (OCT).
- Transcatheter Valve Replacement/Repair
Of the presentations in the transcatheter cardiac valve space, we have highlighted Quality of Life data from the PARTNER II Study evaluating the FDA-approved Sapien 3 and Sapien XT Valves (Edwards) as well as data from products in development including Boston Scientific’s Lotus and Medtronic’s Harmony Transcatheter Pulmonary Valve. Medtronic recently announced FDA approval for the initiation of a Pivotal Investigational Device Exemption (IDE) study to evaluate the Harmony Transcatheter Pulmonary Valve's safety and effectiveness.
- Cerebral Protection
Of the presentations in cerebral protection, we have highlighted top-line results from the pivotal SENTINEL study, which were recently submitted to the FDA as part of the regulatory submission for the Sentinel device (Claret), as well as updated results from PARADIGM-101, an all- comer study evaluating CGuard (InspireMD).
- Structural Heart
Of the presentations in structural heart, we have highlighted updated results from WATCHMAN (Boston Scientific) as well as two products from St. Jude Medical: AMPLATZER PFO Occluder, which received FDA Premarket Approval (PMA) in October 2016, and AMPLATZER Amulet.
- Ventricular Assist Devices (VADs)
Of the presentations on VADs, we have highlighted data from the IMPRESS Study which compared Impella CP (Abiomed) with Intra- Aortic Balloon Pumps (IABP) in reducing mortality in patients with cardiogenic shock. Impella CP, which was originally 510(k) cleared for partial circulatory support for periods up to 6 hours, received FDA Premarket Approval (PMA) approval in April 2016 specifically to provide treatment for ongoing cardiogenic shock.
- Other Coronary/Peripheral Intervention
Additional presentation included 12-month results from the pivotal ILLUMENATE study evaluating the Stellarex Drug-Coated Balloon (Spectranetics) and the DISRUPT PAD/CAD studies evaluating the Shockwave Lithoplasty System (Shockwave Medical) for Peripheral Arterial Disease (PAD) and Coronary Artery Disease (CAD), respectively. Spectranetics recently announced its Premarket Approval (PMA) submission to the FDA for Stellarex which included data from the pivotal ILLUMENATE study. Shockwave received 510(k) clearance in September 2016 for the PAD indication while the CAD indication is only being studied outside the U.S.
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