2017 Buyer’s Guide

This buyer’s guide offers a searchable, comprehensive listing of the FDA-approved interventional devices available in the United States.

Innovations

 

Artis pheno Robotic C-arm Angiography System

Siemens Healthineers
(888) 826-9702
www.healthcare.siemens.com/angio/artis-interventionalangiography-systems/artis-pheno

KEY FEATURES

  • Developed to help hospitals combat infection
  • Software applications facilitate complex procedures
  • Multitilt table supports bariatric patients

The Artis pheno robotic C-arm angiography system was created for minimally invasive interventional procedures and offers 2K imaging resolution. The system is designed, in part, to help hospitals combat patient infection with an antimicrobial coating on the surface of the C-arm, stand, and patient table. The hermetically sealed housing of the C-arm and table modules aid in cleaning the system. In addition, the cabling is routed inside the system to prevent cables from becoming dirty and potentially transmitting bacteria.

The system’s free inner diameter of 37.6 in enables staff to remain at the side of pediatric patients. The patient table accommodates bariatric patients up to 617 lb. The easy-float tabletop can be moved with little effort, regardless of its angle or the patient’s weight. The system recognizes the tabletop’s position and automatically aligns to the tabletop. The Artis pheno also offers a broad array of software applications to aid in a variety of interventional procedures.

The Artis pheno system has received US Food and Drug Administration 510(k) clearance and is available for commercial use in the United States.

Tempo Temporary Pacing Lead

BioTrace Medical Inc.
(650) 779-4999
www.biotracemedical.com

KEY FEATURES

  • Unique soft tip mitigates perforation
  • Stabilizers provide secure fixation
  • Optimized for rapid pacing without dislodgement
  • Facilitates postprocedure ambulation
  • Only active fixation temporary pacing lead available in United States

The Tempo Temporary Pacing Lead from BioTrace Medical Inc. is designed for safe, secure, and stable pacing with the goal of reducing complications and allowing patients to ambulate sooner after procedures, such as transcatheter aortic valve replacement. Cleared by the US Food and Drug Administration in 2016, the Tempo Lead is the only active fixation temporary pacing lead available in the United States. The device features a novel active fixation mechanism and a soft tip to help mitigate the risk of dislodgement and/ or perforation, as well as to ensure stability during rapid pacing.

Results of a multicenter study demonstrated the safety of the Tempo Lead, with no device-related adverse events, dislodgements, sustained ventricular arrhythmia, or cardiac perforation.1 Rapid pacing was successful in all cases with no loss of capture.

“The Tempo Lead is an exciting advance over existing technologies, which can cause complications that result in poor clinical outcomes and longer hospital stays,” said Martin B. Leon, MD, Director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center, and a member of BioTrace Medical’s scientific advisory board.

1. Webster M, Pasupati S, Lever N, Stiles M. “TCT-840 first-in-human experience with a novel active fixation temporary pacing lead: safety and efficacy of the Tempo Lead.” J Am Coll Cardiol. 2016;68:B339-340.

Tryton Side Branch Stent

Cordis, a Cardinal Health Company
www.cordis.com/tryton

KEY FEATURES

  • Only stent FDA approved for the treatment of bifurcation lesions
  • Available in diameters from 2.5 to 3.5 mm in the side branch
  • Compatible with all conventional drug-eluting stents in the main vessel

The Tryton side branch stent* has received US Food and Drug Administration approval.

The stent is indicated for the treatment of coronary bifurcation lesions involving large side branches (appropriate for a ≥ 2.5‑mm stent). The stent is available in multiple device diameters (2.5–3.5 mm in the side branch) and is compatible with any conventional drug-eluting stent in the main vessel.

In a post hoc analysis of a randomized investigational device exemption (IDE) clinical trial, treatment with the Tryton side branch stent in the intended population of patients with large side branches (≥ 2.5-mm stent) led to a statistically significant lower side branch percent diameter stenosis at 9-month follow-up (30.4% vs 40.6%; P = .004) when compared to provisional stenting. The post hoc analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates versus provisional stenting at 3 years.

The safety profile of the Tryton side branch stent was further validated in a confirmatory study that compared patients treated with the Tryton device to a performance goal based on the control arm from the randomized IDE clinical trial.

*Tryton is manufactured by Tryton Medical and distributed by Cordis, a Cardinal Health Company.

 

Contact Info

For advertising rates and opportunities, contact:
Craig McChesney
484-581-1816
cmcchesney@bmctoday.com

Stephen Hoerst
484-581-1817
shoerst@bmctoday.com

Charles Philip
484-581-1873
cphillip@bmctoday.com

About Cardiac Interventions Today

Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.