Medtronic’s IN.PACT Admiral Approval in Japan Boosts APV Arm

Medtronic plc MDT has made another encouraging move with respect to its Aortic & Peripheral Vascular (APV) business. The company recently announced the receipt of regulatory approval for IN.PACT Admiral Drug-Coated Balloon (DCB) from the Japanese Ministry of Health, Labour and Welfare (“MHLW”).

Medtronic’s IN.PACT Admiral DCB gained approval for treating peripheral artery disease (PAD) in the upper leg, – particularly thigh (superficial femoral arteries and behind the knee (popliteal arteries). However, before the commercial launch of the product, Medtronic has to collaborate with Japanese MHLW to attain reimbursement approval. The company believes that reimbursement approval will widen the global customer base for IN.PACT Admiral DCB.

The Japanese regulatory approval was granted to IN.PACT Admiral DCB on the grounds of successful results from the IN.PACT SFA Japan Trial. This development is in line with the company’s strategy to focus on research and development of high-end medical device products within its core business lines.

We note that the IN.PACT Admiral DCB received FDA approval in December 2014 to treat superficial femoral and popliteal arteries. Moreover, it is commercially available in Europe since its receipt of the CE mark approval in 2009. So far, 200,000 PAD patients in Europe have been treated with the device.

Interestingly, Medtronic’s revenues from the APV division improved 4% year over year (up 5% at constant exchange rate) in first-quarter fiscal 2018. Moreover, Peripheral Vascular business grew low double digits in both atherectomy and drug-coated balloons. The latest development should boost the company’s performance in this segment.

Medtronic’s strategy to gain traction in the peripheral vascular sub-segment seems to be aligned with data provided by MarketsAndMarkets . Per the report, the interventional cardiology & peripheral vascular devices market is expected to see a CAGR of 7.1% from 2016 to…

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