Recently, Medtronic (MDT - Free Report) gained the US Food and Drug Administration (FDA) approval for its 34mm and 38mm lengths of the Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm and 4.0mm with an indication for patients with diabetes. The approval will expand the utilization of the marquee product across the domestic market for the interventional treatment of coronary artery disease.
The staple sizes had received the FDA approval earlier in Feb 2012. The latest sizes of the Resolute Integrity drug-eluting stent is already available to cardiac catheterization laboratories across the US as a remedy for long coronary lesions common in diabetic patients. Such long coronary lesions can span more than 27 mm.
According to medical professionals, the novel sizes will address the joint needs of two different but correlated medical problems – long coronary lesions and diabetes. The new sizes of the Resolute Integrity drug-eluting stent is expected to lower vessel trauma and contrast exposure for patients. Additionally, the new sizes of the stent should reduce procedure time as well as costs for clinicians and hospitals.
The company won the FDA approval on the back of the data from the global RESOLUTE clinical program. The results were drawn from a pre-specified analysis of one-year outcomes in patients with long coronary lesions enrolled in the RESOLUTE US and RESOLUTE Asia clinical studies.
The analysis was based on clinical data on 222 patients with coronary lesions of less than 35mm in length. These patients were treated with a 38mm Resolute stent. The main purpose of the analysis was to evaluate a composite indicator of cardiac death, target vessel myocardial infarction termed as target lesion failure (TLF) and clinically-driven target lesion revascularization (TLR) in the patients after one year of treatment. The low TLF and TLR rates, even in diabetic patients, fulfilled the endpoints.
Despite headwinds such as unfavorable currency movement and global economic uncertainties for this leading medical device player, Medtronic is enjoying market share gain on the back of the Resolute Integrity drug-eluting stent under the CardioVascular franchise. Given the burgeoning diabetic population in the US, the approval should drive utilization rates. Acceptance of the new sizes of the stent should bolster growth of the franchise for the company.
Estimate revision trend for Medtronic’s ongoing and next fiscal reflects a glaring lack of clarity. Accordingly, the stock carries a Zacks Rank #3 (Hold). While we have a non-committal stance on Medtronic, other medical stocks carrying a favorable Zacks Rank such as Conceptus , Covidien and Edwards Lifesciences (EW - Free Report) warrant a look. Each of these stocks carry a Zacks Rank #2 (Buy).