Medtronic's IN.PACT Admiral DCB Wins FDA Nod For 150 Mm

The FDA recently approved the marketing of a longer version of Medtronic plc’s (NYSE:MDT) IN.PACT Admiral drug-coated balloon (DCB). This device was available in the market with four types of balloon lengths – 40, 60, 80 and 120 mm. The latest approval was provided for a balloon length of 150 mm.

Notably IN.PACT Admiral DCB is a renowned device in the endovascular therapy market, used to treat superficial femoral artery (SFA), also known as peripheral artery disease (PAD).

PAD and Benefits of IN.PACT Admiral DCB

PAD refers to narrowing of the peripheral arteries, which most commonly affects arteries of the leg. Although treatable, PAD increases one’s risk of coronary heart disease, heart attack, stroke as well as transient ischemic attack. Approximately 8.5 million people in the U.S. currently suffer from PAD, as per estimates of the Centers for Disease Control and Prevention (CDC).

Traditionally Percutaneous Transluminal Angioplasty (PTA) procedure is performed on PAD patients who fail to respond to medication. However, recent clinical studies have supported the advantage of DCB over PTA, in treating lower extremity vascular disease. Medtronic’s IN.PACT Admiral DCB is one such device and has so far successfully proved its superiority over conventional l PTA procedure.

As evident, according to 24-months results from the IN.PACT SFA trial, released in Dec 2015, patients treated with DCB showed significantly higher primary patency (opening up of artery) when compared with PTA. This long-term durability of the IN.PACT DCB compared to PTA was further supported by overall mortality rate in the DCB group being 8.1% versus 0.9% in the PTA group, effectively proving its potency.

As per recently released results from this trial, involving a subgroup of patients with long lesions between 10 and 18 cm, similar superior outcome in favour of Medtronic’s Admiral DCB was demonstrated. Apparently, a clinically-driven target lesion revascularization (CD-TLR) rate of 5.3% was observed in the DCB group, compared to 32.4% for the PTA group.

Without a doubt the latest outcome from the study indicates the advantage of using the IN.PACT Admiral DCB specifically in patients with longer SFA lesions, which in turn encouraged the FDA to clear the device with an extended balloon length for marketing.

Management also remains upbeat about the availability of this longer version of IN.PACT Admiral DCB as it will offer expanded treatment options for patients with longer SFA lesions, who previously might not have been receiving balloon angioplasty treatment at its fullest potential because of the long lesions in their arteries.

Our Take

So far, more than 20 clinical trials have been conducted on Medtronic’s IN.PACT Admiral DCB, each of which demonstrated durable safety and clinical benefits and has led to treatment of over 150, 000 patients.

Apart from durability, the expenses that can be saved from the reduced rates of reintervention when one is treated with Medtronic’s Admiral DCB also makes the choice a cost-effective one.

Interestingly, introduction of drug coated balloons as a peripheral artery device and its gradual popularity has increasingly made this device the most preferred treatment option in the global peripheral artery disease market, in recent years.

With Medtronic being a major player in the medical devices market, with a large customer base spread globally; surely the aforementioned FDA approval will accelerate the demand for its peripheral therapy products, thereby favourably adding to its revenue growth.

Zacks Rank

Medtronic currently holds a Zacks Rank #3 (Hold). Some better-ranked medical stocks areBoston Scientific Corporation (NYSE:BSX) , NuVasive, Inc (NASDAQ:NUVA) and GW Pharmaceuticals plc (NASDAQ:GWPH) . While Boston Scientific and NuVasive sport a Zacks Rank #1 (Strong Buy), GW Pharmaceuticals holds a Zacks Rank #2 (Buy).