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Medtronic Gets FDA Nod for IN.PACT AV for ESRD Patients

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Medtronic plc (MDT - Free Report) announced that it received the FDA clearance for IN.PACT AV drug-coated balloon (DCB) to treat failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) currently undergoing dialysis. The IN.PACT AV DCB is a paclitaxel-coated balloon, which will be used for the treatment.

Patients with ESRD undergo surgeries to create AV fistulae to enable hemodialysis. However, over time the fistulae fail to provide the required access due to vessel restenosis (recurrence of narrowing of blood vessels). To prevent this, Medtronic had been working to bring the technology to surgeons in the United States to help improve the lives of ESRD patients.

The recent approval is expected to strengthen the company’s foothold in the global hemodialysis market and expand its offerings of DCB.



A Peek Into the Study

The FDA approval is based on data from a prospective, global, multicenter, blinded, randomized (1:1), investigational device exemption (“IDE”) study. The study evaluated the safety and effectiveness of the IN.PACT AV DCB on the enrolled patients at 29 sites in the United States, Japan and New Zealand.

The primary end-point of proving the superiority of IN.PACT AV DCB compared to percutaneous transluminal angioplasty (“PTA”) was met by the early data presented at the Cardiovascular Interventional Radiological Society of Europe (“CIRSE”). Further, the data presented at VIVA 2019 stressed on the superior patency of the DCB, with respect to both de novo and restenotic lesions, and all studied types of AV access.

Why is the Approval Significant?

ESRD patients have to undergo maintenance surgeries every year to restore the functioning of the fistula lesions created for hemodialysis, which result in disruptions to critical hemodialysis care and increased healthcare costs. Pivotal randomized results from the IN.PACT AV Access trial proved that it can extend the gap between the reintervention surgeries, thereby maximizing a patient’s uninterrupted access to dialysis care.

Per the company, no treatment was available for AV fistulae lesions, with the ability to maintain primary patency and reduce reinterventions over time until recently. Medtronic believes that the FDA approval will allow it to expand the IN.PACT DCB platform. The company also plans to leverage the technology of its IN.PACT Admiral platform for the same.

Notably, in 2016, the CE Mark for IN.PACT Admiral DCB was expanded for the treatment of failing AV access in patients with ESRD undergoing dialysis.

Industry Prospects

Per a report by Allied Market Research, the global hemodialysis market size was valued at $71,501 million in 2017 and is expected to reach $99,747 million by 2025, witnessing a CAGR of 4.2% from 2018 to 2025. The key factors driving the market are the increasing incidents of hypertension and diabetes, which are leading to rise in the number of ESRD patients.

Given the huge potential of the market, the approval has come at the right time.

Price Performance

The company’s shares have gained 20% in the past year compared with the industry’s growth of 8.1%.

Zacks Rank & Other Key Picks

Currently, Medtronic carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the broader medical space are Haemonetics Corporation (HAE - Free Report) , National Vision Holdings, Inc (EYE - Free Report) and ResMed Inc (RMD - Free Report) .

Haemonetics, currently flaunting a Zacks Rank #1 (Strong Buy), has a projected long-term earnings growth rate of 13.5%.

National Vision’s long-term earnings growth rate is estimated at 17.8%. The company currently sports a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.

ResMed’s long-term earnings growth rate is estimated at 12.9%. It currently flaunts a Zacks Rank #1.

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