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Medtronic Publishes IN.PACT AV Access Trial Study Results

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Medtronic plc (MDT - Free Report) recently published favourable outcome of the IN.PACT arteriovenous (AV) Access trial in The New England Journal of Medicine. Notably, the IN.PACT AV Access study is a randomized controlled trial (RCT). The results demonstrate that the IN.PACT AV drug-coated balloon (DCB) leads to fewer disruptions in dialysis therapy.

The IN.PACT AV Access RCT has covered 29 sites across the United States, Japan, and New Zealand. For investors’ note, the IN.PACT AV DCB is the first and only approved DCB for the treatment of failing AV access, which has met both its endpoints of primary safety and effectiveness unlike the PTA control group.

Medtronic’s Aortic, Peripheral & Venous arm within the broader Cardiac And Vascular Group is expected to progress a step with the latest study outcome.

Significance of the Study Outcome

Patients with end-stage renal disease (ESRD) across the globe regularly undergo hemodialysis, many of them having AV fistulae for receiving continuous dialysis therapy. Such patients with AV fistulae regularly need to maintain access site function. However, the vessels in these access sites may become narrow (restenose) over time and require frequent reinterventions. This can lead to repeated hospital visits and significant disruptions to critical hemodialysis care. Further, such patients are at higher risks of acquired infections, which makes frequent hospital visits risky.

However, the IN.PACT AV DCB study results (based on six-month data) establish that the DCB can significantly reduce the number of reinterventions required to maintain vessel patency (blood flow). This is expected to lead patients to experience longer periods of successful and uninterrupted dialysis.

Per the medical fraternity, apart from benefitting patient lives, the IN.PACT AV DCB also illustrated that it can lead to significant reductions in projected costs to the healthcare system.

Industry Prospects

Per a report by Research And Markets, the global DCB market is expected to reach revenues of more than $1 billion by 2024 at a CAGR of around 17% between 2018 and 2024. Factors like increasing advancements in endovascular therapy, increasing demand for less invasive surgeries and growing awareness about vascular diseases are expected to drive the market.

Given the market potential, the favorable study outcomes are expected to significantly boost Medtronic’s business.

Recent Developments in Cardiac And Vascular Group

Of late, Medtronic has been witnessing a slew of developments in this business arm.

In July, the company received the FDA’s approval and CE Mark for its LINQ II insertable cardiac monitor with remote programming. The same month, Medtronic announced the start of a prospective, observational, global, multi-center, real-world, post-market study to assess the safety and effectiveness of the Valiant Navion Thoracic Stent Graft System for the treatment of thoracic aortic dissection.

In June, Medtronic reported new data from the Global SYMPLICITY Registry, which showed that renal denervation (RDN) with the company’s Symplicity RDN System significantly reduced blood pressure in patients with uncontrolled hypertension out to three years, without any anti-hypertension medication burden.

In the same month, the company announced the receipt of the CE Mark for its Evolut Transcatheter Aortic Valve Implantation system and its subsequent Europe launch for patients with severe native aortic stenosis who are at low risk of surgical mortality. Further, Medtronic received the CE Mark for its Micra atrioventricular Transcatheter Pacing System.

Also, Medtronic announced the receipt of the CE Mark for its one-month dual antiplatelet therapy indication to address high bleeding risk patients who are implanted with the Resolute Onyx Drug-Eluting Stent.

In May, the company announced the U.S. launch of Kyphon Assist Directional Cannula to be used with its balloon kyphoplasty products to treat vertebral compression fractures due to osteoporosis, cancer or benign lesions.

Price Performance

Shares of the company have lost 6.5% in the past year compared with the industry’s 5.6% fall and against the S&P 500’s 15.6% growth.

Zacks Rank & Key Picks

Currently, Medtronic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are QIAGEN N.V. (QGEN - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Hologic, Inc. (HOLX - Free Report) .

QIAGEN’s long-term earnings growth rate is estimated at 22.3%. It currently flaunts a Zacks Rank #1. (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Thermo Fisher’s long-term earnings growth rate is estimated at 15%. It currently carries a Zacks Rank #2 (Buy).

Hologic’s long-term earnings growth rate is estimated at 15.5%. The company presently sports a Zacks Rank #1.

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