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Medtronic's (MDT) Cryoablation Catheters Get FDA Expanded Nod
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Medtronic plc (MDT - Free Report) recently announced the receipt of the FDA’s expanded approval for Freezor and Freezor Xtra Cardiac Cryoablation. This approval is likely to bolster Medtronic’s cardiac Ablation Solutions business, which is part of the company’s Cardiovascular Portfolio.
Cardiac Cryoablation is the only ablation catheter approved to treat pediatric Atrioventricular Nodal Reentrant Tachycardia (AVNRT).
AVNRT is a life-threatening abnormal heart rhythm and is the most common form of supraventricular tachycardia (SVT), with 89,000 cases each year and rising.
It is worth mentioning that Medtronic has pioneered cryoablation technology with an extensive body of evidence, including proven safety and efficacy in treating AF and AVNRT. To date, more than one million patients have been treated with Medtronic’s cryoablation therapy globally.
More on Catheter Ablation
The Freezor and Freezor Xtra Catheters are flexible, single-use devices used to freeze cardiac tissue and block redundant electrical signals within the heart. The Freezor cardiac cryoablation catheter was first commercially available in the United States for adult use of AVNRT in 2003, followed by the Freezor Xtra cardiac cryoablation catheter launch in 2016.
Cryoablation catheters can minimize the risk of permanent AV block, a complication of AVNRT procedures performed with radiofrequency (RF) ablations that lead to the partial or complete interruption of the heart's electrical signals, which dangerously disrupt heart rhythm.
Image Source: Zacks Investment Research
The expanded indication approval of Cardiac Cryoablation catheters is backed by results from ICY-AVNRT and multiple pediatric randomized, multi-center studies that showed the safety and effectiveness of the treatment of AVNRT using the Freezor and Freezor Xtra cardiac cryoablation catheters. ICY-AVNRT data demonstrated acute procedural success of 95% with no reports of permanent pacemaker due to complete AV block.
Significance of Expanded Indication
With an FDA expanded indication, the Freezor and Freezor Xtra cardiac cryoablation catheters will enable even the youngest cardiology patients to access a safe, life-enhancing technology that will help advance cardiac care for AVNRT.
Per Medtronic’s management, the shared commitment to collaborate and grow cardiac cryoablation therapy's unique position to treat AVNRT patients demonstrates the company’s confidence in the cryoablation technology's proven safety and efficacy.
The growing geriatric population coupled with an increasing population base of cardiovascular disease patients, increasing demand for minimally-invasive cardiac treatment procedures, and growing awareness about the benefits of cardiac ablation procedures are the factors driving the market.
Recent Developments
In January 2022, Medtronic announced that the Micra AV Transcatheter Pacing System has been approved for sale and reimbursement by Japan's Ministry of Health, Labor and Welfare (MHLW). The Micra AV is used to treat patients who have atrioventricular (AV) block.
In the same month, Medtronic announced that the National Medical Products Administration approved the CoreValve Evolut PRO TAVR system to treat severe aortic stenosis for symptomatic patients in China who are at high or extreme risk for open-heart surgery.
Price Performance
Shares of the company have lost 13% in a year compared with the industry's fall of 18.5%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #4 (Sell).
A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. (AMN - Free Report) , Henry Schein, Inc. (HSIC - Free Report) and West Pharmaceutical Services, Inc. (WST - Free Report) .
AMN Healthcare, carrying a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, on average. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
AMN Healthcare has outperformed its industry over the past year. AMN has gained 23.8% against the 62% industry decline.
Henry Schein has an estimated long-term growth rate of 11.8%. Henry Schein’s earnings surpassed estimates in the trailing four quarters, the average surprise being 21.86%. It currently carries a Zacks Rank #1.
Henry Schein has gained 6.1% compared with the industry’s 1.7% rise over the past year.
West Pharmaceutical has a long-term earnings growth rate of 27.6%. West Pharmaceutical surpassed earnings estimates in the trailing four quarters, delivering an average surprise of 29.4%.
West Pharmaceutical has outperformed its industry over the past year. WST currently carries a Zacks Rank of 2.
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Medtronic's (MDT) Cryoablation Catheters Get FDA Expanded Nod
Medtronic plc (MDT - Free Report) recently announced the receipt of the FDA’s expanded approval for Freezor and Freezor Xtra Cardiac Cryoablation. This approval is likely to bolster Medtronic’s cardiac Ablation Solutions business, which is part of the company’s Cardiovascular Portfolio.
Cardiac Cryoablation is the only ablation catheter approved to treat pediatric Atrioventricular Nodal Reentrant Tachycardia (AVNRT).
AVNRT is a life-threatening abnormal heart rhythm and is the most common form of supraventricular tachycardia (SVT), with 89,000 cases each year and rising.
It is worth mentioning that Medtronic has pioneered cryoablation technology with an extensive body of evidence, including proven safety and efficacy in treating AF and AVNRT. To date, more than one million patients have been treated with Medtronic’s cryoablation therapy globally.
More on Catheter Ablation
The Freezor and Freezor Xtra Catheters are flexible, single-use devices used to freeze cardiac tissue and block redundant electrical signals within the heart. The Freezor cardiac cryoablation catheter was first commercially available in the United States for adult use of AVNRT in 2003, followed by the Freezor Xtra cardiac cryoablation catheter launch in 2016.
Cryoablation catheters can minimize the risk of permanent AV block, a complication of AVNRT procedures performed with radiofrequency (RF) ablations that lead to the partial or complete interruption of the heart's electrical signals, which dangerously disrupt heart rhythm.
The expanded indication approval of Cardiac Cryoablation catheters is backed by results from ICY-AVNRT and multiple pediatric randomized, multi-center studies that showed the safety and effectiveness of the treatment of AVNRT using the Freezor and Freezor Xtra cardiac cryoablation catheters. ICY-AVNRT data demonstrated acute procedural success of 95% with no reports of permanent pacemaker due to complete AV block.
Significance of Expanded Indication
With an FDA expanded indication, the Freezor and Freezor Xtra cardiac cryoablation catheters will enable even the youngest cardiology patients to access a safe, life-enhancing technology that will help advance cardiac care for AVNRT.
Per Medtronic’s management, the shared commitment to collaborate and grow cardiac cryoablation therapy's unique position to treat AVNRT patients demonstrates the company’s confidence in the cryoablation technology's proven safety and efficacy.
Industry Prospects
Per a report by Markets and Markets, the global cardiac ablation catheters market is poised to see a CAGR of 11.5% during 2016-2021.
The growing geriatric population coupled with an increasing population base of cardiovascular disease patients, increasing demand for minimally-invasive cardiac treatment procedures, and growing awareness about the benefits of cardiac ablation procedures are the factors driving the market.
Recent Developments
In January 2022, Medtronic announced that the Micra AV Transcatheter Pacing System has been approved for sale and reimbursement by Japan's Ministry of Health, Labor and Welfare (MHLW). The Micra AV is used to treat patients who have atrioventricular (AV) block.
In the same month, Medtronic announced that the National Medical Products Administration approved the CoreValve Evolut PRO TAVR system to treat severe aortic stenosis for symptomatic patients in China who are at high or extreme risk for open-heart surgery.
Price Performance
Shares of the company have lost 13% in a year compared with the industry's fall of 18.5%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #4 (Sell).
A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. (AMN - Free Report) , Henry Schein, Inc. (HSIC - Free Report) and West Pharmaceutical Services, Inc. (WST - Free Report) .
AMN Healthcare, carrying a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, on average. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
AMN Healthcare has outperformed its industry over the past year. AMN has gained 23.8% against the 62% industry decline.
Henry Schein has an estimated long-term growth rate of 11.8%. Henry Schein’s earnings surpassed estimates in the trailing four quarters, the average surprise being 21.86%. It currently carries a Zacks Rank #1.
Henry Schein has gained 6.1% compared with the industry’s 1.7% rise over the past year.
West Pharmaceutical has a long-term earnings growth rate of 27.6%. West Pharmaceutical surpassed earnings estimates in the trailing four quarters, delivering an average surprise of 29.4%.
West Pharmaceutical has outperformed its industry over the past year. WST currently carries a Zacks Rank of 2.