Last week, leading medical devices player,
) announced that the US Food and Drug Administration ("FDA") has
selected one of its stent grafts for a pilot program. The Valiant
Mona LSA system, one of the nine products selected for the early
feasibility program, is a stent graft designed to repair a
descending thoracic aortic aneurysm ("TAA") encroaching on the left
The FDA to encourage and facilitate early feasibility studies of
innovative medical devices in the US had published a guidance
document in 2011. We are encouraged with the agency choosing
Medtronic's device for the pilot program.
A thoracic aortic aneurysm (TAA) is a swelling in the body's
main artery near where it originates from the heart. If left
untreated, a TAA can burst, leading to a situation where extensive
internal bleeding usually leads to death. A thoracic stent graft,
delivered through a pre-loaded catheter inserted in the patient's
femoral artery, conforms to the wall of the aorta creating a new
path for blood flow that reduces pressure on the aneurysm and the
risk of rupture.
Medtronic's Valiant Captivia Stent Graft is approved by the FDA
for endovascular repair of aneurysms. The device selected for the
pilot program is based on the Valiant Captivia Thoracic Stent Graft
During the most recent quarter, revenues from the company's
Endovascular & Peripheral segment recorded a robust 10% growth.
This was due to the worldwide success of the Endurant abdominal
stent graft, including Japan where it was recently launched. While
Endurant II is performing well in Europe (CE Mark approved December
2011), its recent launch in the US should enable the company to
garner additional revenues in the quarters ahead.
Acknowledging the challenges at play in its core segments,
Medtronic is in the process of launching several new products that
are likely to drive growth in this difficult scenario. Many of the
recently launched products are contributing significantly to the
top line. Besides, the company is increasing its focus on the
emerging markets. Such a strategy is also being followed by its
St Jude Medical
We have a Neutral recommendation on Medtronic. The stock retains
a Zacks #3 Rank (hold) in the short term.
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