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Medtronic's Avalus Aortic Surgical Valve Results Favorable


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Medtronic plc (MDT - Analyst Report) recently announced positive data from the PERIGON (Pericardial Surgical Aortic Valve Replacement) pivotal trial evaluating its investigational Avalus pericardial aortic surgical valve for the treatment of aortic valve disease. For the first time, the results from the study were presented at the 30th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting. The results demonstrated low rates of adverse valve-related incidents, high survival and improved hemodynamic performance.

The PERIGON pivotal trial is a single arm, non-randomized, prospective study of approximately 1,300 patients from 40 clinical sites across Europe, Canada, Japan and the United States. The trial was carried out in 270 patients for a period of one year with Medtronic’s Avalus valve. At the end of the year, all patients showed low rates of all-cause mortality and cardiac death.

The primary analysis demonstrated positive clinical outcomes with low linearized rates of thromboembolism, endocarditis, paravalvular leaks and hemorrhages. No thrombosis, hemolysis, severe paravalvular leaks or structural valve deterioration were observed during this time frame. Additionally, patients treated with the Avalus valve witnessed enhanced hemodynamic (blood flow) performance.

Avalus pericardial aortic surgical valve has been developed in close collaboration with expert surgeons for easy use. The PERIGON trial showed the positive contributions of Avalus to valve performance and clinical results. It allows surgeons to better understand the modern SAVR treatment from this comprehensive trial dataset compared to earlier studies. The Avalus valve is not approved for commercial use in the United States or Europe.

According to a Research and Markets report, the global heart valves market has been projected to grow at a CAGR of 14.28% during 2016–2020. Medtronic’s management is encouraged by the positive outcome of its superior Avalus valve. We feel that this would help the company expand its offering for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

For quite some time now, Medtronic has been delivering good performance in its cardiac and vascular segments. As per the company’s recently concluded quarterly report, the segment experienced a steady growth rate. Recently Medtronic gained FDA approval for its IN.PACT Admiral drug-coated balloon (DCB) for the treatment of in-stent restenosis in patients with peripheral artery disease.

Zacks Rank & Key Picks

Medtronic currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical product sector are GW Pharmaceuticals plc (GWPH - Analyst Report) , Quidel Corp. (QDEL - Snapshot Report) and NuVasive, Inc. (NUVA - Analyst Report) . GW Pharmaceuticals and Quidel sport a Zacks Rank #1 (Strong Buy) while NuVasive carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

GW Pharmaceuticals recorded a 91.07% gain year to date, far better than the S&P 500’s 5.74% over the same time frame. The trailing four-quarter average earning surprise is 41.67%.

Quidel gained 12.42% in the past one year, higher than the S&P 500’s 8.76%. Over the next five years, the stock is estimated to record earnings growth rate of 20%, higher than the industry average of 14.8%.

NuVasive surged 26.13% over the past one year compared to the S&P 500’s 8.76%. Over the next five years, the stock is expected to see 16.7% earnings growth compared to the industry average of 14.8%.

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