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FDA approves Medtronic’s CoreValve: Will a second device shake up the TAVR market?

January 24, 2014

Vanessa Lo, Technology Insights

On Friday, Jan. 17, Medtronic announced the U.S. Food and Drug Administration (FDA) approval of CoreValve, a self-expanding transcatheter aortic valve replacement (TAVR) system, for surgically ineligible aortic stenosis patients. Interestingly, the approval of the CoreValve occurred without an independent FDA advisory panel review. 

In a surprising 2013 annoucement, the FDA announced it would not require an advisory committee to evaluate whether the data supported approval, stating that data from the CoreValve Extreme Risk Trial, which assessed the safety and efficacy of the TAVR device for patients that are too high risk to be treated with conventional aortic valve replacement surgery, would be sufficient. 

The study demonstrated that the CoreValve system is safe and effective with high rates of survival and some of the lowest stroke and paravalvular leak rates seen in any studies thus far.

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Recent renal denervation trial fails to meet primary efficacy endpoint: What now?

January 23, 2014

Vanessa Lo, Technology Insights

Last week, Medtronic announced the major results of SYMPLICITY HTN-3, its U.S. pivotal trial for their renal denervation system for treatment-resistant hypertension. The large multi-center, randomized, controlled study was designed to assess the efficacy of the procedure by including a control arm that underwent a sham procedure. 

While the study met its primary safety endpoint, it failed to meet its primary efficacy endpoint, a sustained reduction in systolic blood pressure at six months.

In the United States, the FDA has yet to approve a renal denervation system. Cardiovascular experts anticipated that Medtronic’s Symplicity device would be the first to receive FDA approval given its clinical trial progress. However, with the negative results of SYMPLICITY HTN-3, the future of Medtronic’s Symplicity is uncertain, as well as renal denervation for treatment of hypertension.

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Watchman LAA device gets one step closer to FDA approval

January 3, 2014

Rory Lubner, Technology Insights

On December 11th, 2013, Food and Drug Administration advisors voted 13-1 that the benefits associated with Boston Scientific’s Watchman device outweighed the risks in atrial fibrillation (AF) patients. 

This overwhelmingly strong support for the technology will aid the FDA in its upcoming approval decision for commercial use in the United States.

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Despite FDA clearance, FIRM ablation’s impact still unknown

December 6, 2013

Haley David and Rory Lubner, Technology Insights

Earlier this month, Topera Medical announced FDA 510(k) clearance of its FIRMap catheter, a diagnostic mapping catheter that helps target the source of a patient’s arrhythmia. This catheter, in combination with the company’s FDA-cleared RhythmView 3D Mapping Workstation, represents an innovative service for highly progressive electrophysiology (EP) programs across the country.

The diagnostic basket catheter and mapping system are key components of a progressive EP procedure known as FIRM ablation. During the procedure, the mapping catheter and system allow electrophysiologists (EPs) to view specific areas in the heart—or “rotors”—which may cause an arrhythmia to occur. FIRM ablation strives to pinpoint these underlying mechanisms sustaining complex arrhythmias, most notably atrial fibrillation (AF). 

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MEDICA 2013: How sudden is sudden cardiac death?

December 2, 2013

Vanessa Lo, Clinical Investment Insights

On Wednesday, November 20th, MEDICA, the world’s largest annual medical technology conference, brought thousands of clinical experts from over 100 countries to Düsseldorf, Germany to learn about new innovations in inpatient and ambulatory care. 

In addition to showcasing the newest service line technologies transforming patient care, the conference highlighted important developments in sports medicine, including prevention of sudden cardiac death (SCD) in professional football players.

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TCT 2013: The most important result of this trial isn’t the data

November 4, 2013

Haley David, Technology Insights

The most interesting late-breaking clinical trial presented at this year’s TCT conference—in our opinion—was the SAFE-PCI trial, which studied the efficacy and feasibility of radial access percutaneous coronary interventions (PCI) in women. 

While the trial did not achieve statistical significance with regard to its primary endpoint, it did introduce several thought-provoking “firsts” in interventional cardiology research.

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TCT 2013: Structural heart disease—the new CV frontier

October 31, 2013

All week, The Pipeline has been learning the latest in interventional cardiovascular medicine at the 25th annual Transcatheter Cardiovascular Therapeutics conference in San Francisco. Check back regularly, or subscribe to blog alerts to stay up-to-date.

Haley David, Technology Insights

This year’s Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco marks the 25th anniversary of the scientific symposium. Reflecting on the conference’s evolution, the powerful opening session showcased just how far the field of interventional cardiology has come since 1988, leaving many in the audience speechless. 

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TCT 2013: MitraClip’s FDA approval—expanding valve disease treatment

October 31, 2013

Rory Lubner, Technology Insights

On Friday, October 25th, the Food and Drug Administration (FDA) approved Abbott Vascular’s catheter-based MitraClip device to treat patients with significant symptomatic degenerative mitral regurgitation (MR) who are at prohibitive risk for mitral valve surgery.

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