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Medtronic Receives FDA Nod For SelectSite Catheter System

Published 05/30/2019, 07:46 AM
Updated 07/09/2023, 06:31 AM
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Medtronic plc (NYSE:MDT) recently announced the FDA clearance for SelectSite C304-HIS deflectable catheter system and its market launch. The system will be used in procedures that involve His-bundle pacing (“HBP”). The launch of the catheter is in line with the company’s goal to expanding its cardiac care portfolio.

For investors’ notice, HBP is a physiologic substitute to right ventricular pacing, in which a pacing lead is positioned at or near the bundle of His, using the heart`s innate His-Purkinje conduction system to reinstate normal rhythm.

More About the SelectSite

The SelectSite C304-HIS deflectable catheter system is equipped with a deflectable, out-of-plane curve to reach the bundle of His and is capable of offering enhanced range maneuverability, fixation as well as implant success for a broader variety of patient anatomies. Its adjustable form enables the accommodation and securing of the pacing lead in more complex anatomies, including patients with a large right atrium.

The new catheter system ensures positioning of the Medtronic SelectSecure MRI SureScan Model 3830 cardiac pacing lead. It is the only pacing lead available in the U.S. market which has been approved for HBP.

Market prospects

Per Research and Markets, the global cardiovascular catheters market is estimated to register a CAGR of 7.4% during the period 2017-2021. Hence, the launch of the product is well-timed.

Recent Developments

Of late, a few of Medtronic’s crucial developments are likely to strengthen the cardiovascular portfolio.

For instance, the company recently announced its foray into the guide extension catheter market with the global launch of the TelescopeGuide Extension Catheter. It is a newly-designed catheter used to provide additional backup support and access to distal lesions. Guide extension catheters enable the delivery of coronary stents, balloons and other interventional devices during angioplasty procedures that help to reinstate blood flow through the coronary and peripheral arteries.

In May, Medtronic attained FDA approval for the Attain Stability Quad MRI SureScan left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and pacemakers (CRT-P), the Attain Stability Quad lead is the sole active-fixation left heart lead. It is known for offering for precise lead placement and stability.

Price Performance

Buoyed by these developments, Medtronic has outperformed its industry in the past year. The stock has improved 8.3%, against the industry’s 1.7% rise.

Zacks Rank and Key Picks

Medtronic currently holds a Zacks Rank #3 (Hold). Few better-ranked stocks in the broader medical space are Cerner Corporation (NASDAQ:CERN) , Penumbra (NYSE:PEN) and Bruker Corporation (NASDAQ:BRKR) . While Cerner sports a Zacks Rank #1 (Strong Buy), Penumbra and Bruker carry a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Cerner’s long-term earnings growth rate is expected to be 13.5%.

Penumbra’s long-term earnings growth rate is projected at 21.5%.

Bruker’s long-term earnings growth rate is estimated at 11.7%.

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Cerner Corporation (CERN): Free Stock Analysis Report

Bruker Corporation (BRKR): Free Stock Analysis Report

Penumbra, Inc. (PEN): Free Stock Analysis Report

Medtronic PLC (MDT): Free Stock Analysis Report

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