Medtronic Gets FDA's Breakthrough Device Nod for Valiant TAAA

Medtronic plc MDT recently obtained the Breakthrough Device designation from the FDA for its Valiant TAAA Stent Graft System, designed for the minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA).

This latest approval is expected to expand Medtronic’s Aortic, Peripheral & Venous line within the broader Cardiac and Vascular group.

More About Valiant TAAA

The Valiant TAAA is currently under evaluation in the United States in five physician-sponsored investigational device exemption (PS-IDE) trials, which are being conducted for the treatment of TAAA. The Valiant TAAA aims to offer an endovascular solution with a size matrix that will enable patient applicability for one of vascular surgery’s most complex pathologies.

This designation from the FDA will enable surgeons to deliver swifter treatment to patients in need. Henceforth, the agency will offer Medtronic facilities like Priority Review and interactive communication pertaining to device development, clinical trial protocols and decisions of commercialization.

 

This designation for Valiant TAAA and Medtronic’s collaboration with leading physicians are in sync with its commitment to overcome the limitations of currently prevailing treatment options.

Market Prospects

Per Grand View Research, the global aortic aneurysm market reached a worth of $2.5 billion in 2018 and is anticipated to witness a CAGR of 8.6% from 2019 to 2026. Hence, the FDA’s designation has come at an ideal time.

Recent Developments

In the first quarter of fiscal 2020, Medtronic registered double-digit revenue growth from its Valiant Navion thoracic stent graft. In May, the Valiant Navion LSA branch thoracic stent graft system received the Breakthrough designation from the FDA, which enabled faster and more efficient delivery of treatment to patients in need of left subclavian artery (LSA) coverage during thoracic endovascular aortic repair (TEVAR).

Price Performance

In the past three months, the company’s shares have gained 6.3% against the industry’s 2.6% fall.

Zacks Rank & Other Key Picks

Medtronic currently has a Zacks Rank #2 (Buy).

A few other similar-ranked stocks in the broader medical space are Stryker SYK, Hill-Rom Holdings HRC and Syneos Health SYNH. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Stryker’s long-term earnings growth rate is expected to be 10.04%.

Hill-Rom Holdings’ long-term earnings growth rate is projected at 10.01%.

Syneos Health’s long-term earnings growth rate is expected to be 10.5%.

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