) released new data at EuroPCR 2014 which demonstrates better
clinical outcomes for patients treated with the self-expanding
These patients were enrolled under the rigorous "real world"
Medtronic CoreValve ADVANCE Study. This transcatheter aortic valve
implantation (TAVI) study reported low rates of mortality and
stroke, and showed exceptional valve performance in the patients,
over a period of two years.
The study results took 96.8% of 1,015 patients into account, all
of whom had severe aortic stenosis and were treated with the
CoreValve System. Of these patients, 25.6% experienced low rates of
all-cause mortality, 16.8% cardiovascular mortality and 2.9% major
stroke at two years.
Majority of the patients under the scope of the study
experienced dramatic improvement in symptoms through two years,
with strong and stable improvement in their overall hemodynamic
performance. The average hemodynamic resistance for these patients
remained below 10mmHg, which is a commonly used threshold of
exceptional blood flow. Such positive results confirm the safety,
efficacy and excellence of the CoreValve System.
The international ADVANCE Study was conducted by experienced
TAVI heart teams across 44 centers in 12 countries. It calculated
clinical endpoints according to Valve Academic Research Consortium
(VARC) standardized definitions. All data were independently
monitored and all adverse events related to primary endpoints were
judged by an independent Clinical Events Committee (CEC) comprising
experienced cardiac surgeons and interventional cardiologists.
In a separate analysis conducted under this ADVANCE study,
patients aged 75 years and below were compared with older patients.
The purpose of this analysis was to show that both age groups
benefited from CoreValve treatment, demonstrating similar and low
all-cause mortality rates at 30 days, 12 months and 2 years.
Further, no significant differences were found between the two
age groups for rates of cardiovascular mortality, stroke,
myocardial infarction, bleeding, moderate and severe paravalvular
leak, or the need for a new permanent pacemaker at either one or
Medtronic's CoreValve System has been approved by the U.S. Food
and Drug Administration (FDA) in Jan 2014 for patients who are at
extreme risk for surgery. However, for other patient groups, the
U.S., CoreValve System is still investigational. Since the receipt
of CE (Conformité Européenne) Mark in 2007, the CoreValve System
has been implanted in more than 60,000 patients in above 60
Medtronic currently has a Zacks Rank #3 (Hold). Some
better-ranked stocks worth considering in the biomedical industry
ANI Pharmaceuticals, Inc.
Myriad Genetics Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).
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