Medtronic Puts First Patient in IN.PACT AV Access DCB Study
One of the world’s largest medical technology, services and solutions companies, Medtronic plc MDT, announced the first patient enrollment under its IN.PACT AV Access Drug-Coated Balloon (DCB) study for patients with end-stage renal disease (ESRD).
Notably, the U.S. Food and Drug Administration (FDA) allowed the investigational device exemption (IDE) study to evaluate the safety and usefulness of IN.PACT AV Access DCB to treat failing arteriovenous (AV) fistulas in ESRD patients. This study will extend for up to two years at approximately 30 sites in the U.S., Japan and New Zealand.
This study has been designed to provide advanced clinical options for patients with restricted AV access. According to the company, DCBs are supported by clinical evidence in patients with peripheral artery disease (PAD) in the upper leg. Management is hopeful that this study will provide data to support the DCB’s use to improve patency and reduce the need for repeat interventions in AV access sites for patients on dialysis. The primary efficacy endpoint is patency of dialysis fistulas over six months while the primary safety endpoint is serious adverse events over 30 days.
Maintaining patency at AV access sites for dialysis patients is a challenge. The advancement of this study demonstrates the company’s sheer commitment to address challenging lesions and improve care for patients with ESRD. While the market for end-stage renal disease therapy is expanding rapidly, we find Medtronic’s focus on strengthening its foothold in this niche area to be strategic.
According to transparency market research, the global peripheral vascular devices market is expected to grow from $4.8 billion in 2011 to $7.8 billion by 2018. It also states that the global peripheral vascular devices market is expected to expand at a 7.10% CAGR during the 2012 to 2018 period.
Also, a report published by Market Data Forecast states that the peripheral vascular device market is estimated to reach $10.24 billion by 2021 at a CAGR of 7.2%.
In this regard, we note that for the past three months, Medtronic has been trading above the Zacks categorized Medical - Products industry. The stock has gained 4.9%, better than the industry’s addition of 0.8%.
Recent Developments in this Niche Area
New sub-analyses from the IN.PACT Global Study have been unveiled at two "Podium First" presentations on Apr 25, 2017. The studies focus on real-world patient outcomes, including the durability, safety and efficacy of the IN.PACT(TM) Admiral(TM) DCB to treat challenging and complex lesions in patients with peripheral artery disease.
The VenaSeal(TM) closure system has been featured in two key clinical presentations, including the three-year results of Medtronic's pivotal VeClose study and 12-month results from the WAVES study – which an independent and physician-sponsored.
Zacks Rank & Key Picks
Medtronic currently carries a Zacks Rank #4 (Sell). Better-ranked stocks in the broader medical sector are Luminex Corporation LMNX, Inogen, Inc. INGN and Edwards Lifesciences Corporation EW. Notably, Luminex and Inogen sport a Zacks Rank #1 (Strong Buy), while Edwards Lifesciences carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Luminex has an expected long-term adjusted earnings growth of almost 16.3%. The stock added roughly 6.8% over the last three months.
Inogen has a long-term expected earnings growth rate of 17.5%. The stock has a solid one-year return of around 81.7%.
Edwards Lifesciences has an expected long-term adjusted earnings growth of almost 15.6%. The stock added roughly 14.8% over the last one year.
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