Medtronic received clearance to sell its Valiant Navion thoracic stent graft system in Japan, the company said Thursday.
The device's Japanese market go-ahead for use in the minimally invasive repair of thoracic descending aortic aneurysms and complicated type B aortic dissections follows U.S. and Europe launches.
- Valiant Navion will slot into a Japanese portfolio of aortic, peripheral and venous devices that has offset weakness in other developed markets in recent quarters.
Medtronic won FDA approval for the low-profile thoracic endovascular aneurysm repair endograft in October 2018 and picked up a CE mark in Europe the following month. Those regulatory decisions cleared Medtronic to start pitching Valiant Navion for use in the repair of lesions in patients with small iliac arteries.
In its two most recent sets of financial results, Medtronic singled out the introduction of Valiant Navion as a key driver of rising sales at the thoracic aortic aneurysm franchise which grew between the mid-teens and low-20s over that period.
Adding Japan to the list of markets in which Valiant Navion is sold could help Medtronic to maintain momentum. Hideyuki Shimizu, director of the Japanese Society for Vascular Surgery, said in Medtronic's announcement the device is well suited to the Japanese market.
"In Japan, patients experience greater aortic fragility in acute dissection compared to North America and Europe," Shimizu said in the statement. "In my experience, Valiant Navion’s 18F profile allows physicians to treat smaller and more torturous anatomy while managing patient populations with increased inflammatory states, risks of hypertension, and aortic wall stress — all attributes and conditions that are particularly relevant to the Japanese patient population."
Medtronic groups Japan with Australia, New Zealand, Korea, Canada, and Western Europe under the umbrella of non-U.S. developed markets in its financial results without isolating individual countries' performance. But at the time of its fourth quarter results in April, Medtronic highlighted the effect of Japan on sales of drug-coated balloons.
Uncertainty about the safety of paclitaxel, the drug used in the coating, caused sales of the devices to fall by more than 20% in the U.S. and Western Europe in the quarter. However, global sales of the balloons only suffered a high-single-digit drop, in part because growth in Japan offset declines in other markets. Valiant Navion is part of the same business unit as the balloons.