Medtronic plc MDT released the preliminary results from the IN.PACT AV Access clinical study. The study compared the investigational IN.PACT AV drug-coated balloon (DCB) with percutaneous transluminal angioplasty (PTA) in patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions.
The results of the study, which met all primary safety and effectiveness endpoints, will prove to be a major stride forward for the company’s endeavor to treat patient suffering from renal diseases. This will likely be a major breakthrough in the Aortic Peripheral Ventricular (APV) business segment.
Details of the Results
The IN.PACT AV Access study is a randomized controlled trial (RCT), which has enrolled 330 subjects at 29 sites in United States, Japan and New Zealand.
The study enrolled a complex patient population, which has been undergoing dialysis for an average of 4.3 years. Overall, the IN.PACT AV DCB group highlighted clinical benefit compared with the PTA control group. Among several crucial findings of the study, an outcome indicated that the primary patency rate of the target lesion at 180 days was 86.1% in the IN.PACT AV DCB group compared with 68.9% in the PTA control group.
Moreover, per the Kaplan-Meier estimates, freedom from all-cause death through 360 days was 90.6% in the IN.PACT AV DCB study group compared with 90.4% in the PTA control group. The information complements the initial safety data presented at the FDA’s Advisory Committee meeting of the Circulatory System Devices Panel in June, which showed no difference in mortality rates in this patient population. These results assure that IN.PACT AV DCB not only addresses AV fistulae lesions, but also enhances the quality of life of patients undergoing dialysis.
This newly-released data showcases the potential of IN.PACT AV DCB to treat restenosis in high-risk patients who currently avail few long-term treatment options.
In the United States, the IN.PACT AV DCB is an investigational device and has not yet attained regulatory approval for commercial use. In January 2016, the CE indication for the IN.PACT Admiral DCB was extended for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis.
Glimpse of APV Business
In first-quarter fiscal 2020, APV revenues rose 1.7% at CER (down 0.2% as reported) to $467 million on high-single-digits growth in Venous and mid-single digits rise in Aortic. The upsides were partially offset by high-single digits decline in Peripheral.
Per a report by MarketsAndMarkets, the peripheral vascular devices market is expected to see a CAGR of 6.8% and reach $14.4 billion by 2024.
We believe that rising cases of peripheral artery disease, penetration of companies in untapped markets, more demand for minimally-invasive angioplasty procedures, technological advancements and increasing awareness among people will continue to drive global acceptance of the technology. Considering encouraging factors, we believe that the company’s development regarding IN.PACT Admiral DCB is strategic and is expected to broaden its customer base.
The stock has rallied 12.3% in the past year compared with the industry’s 0.2% growth.
Zacks Rank and Other Stocks Worth a Look
Medtronic currently has a Zacks rank # 2 (Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Amedisys ’s long-term earnings growth rate is expected to be 16.26%.
Baxter’s long-term earnings growth rate is projected at 12.8%.
Haemonetic’s long-term earnings growth rate is expected to be 13.5%.
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