Medtronic Unveils New CoreValve Data - Analyst Blog

Medtronic, Inc. MDT released new data at EuroPCR 2014 which demonstrates better clinical outcomes for patients treated with the self-expanding CoreValve System.

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 two years.

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 countries.

Medtronic currently has a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering in the biomedical industry include ANI Pharmaceuticals, Inc. ANIP, Myriad Genetics Inc. MYGN and Illumina Inc. ILMN. All these stocks carry a Zacks Rank #1 (Strong Buy).