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Medtronic Resolute Onyx Gets CE Mark for 1-Month DAPT Therapy
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Medtronic plc (MDT - Free Report) announced the receipt of the CE Mark for its one-month dual antiplatelet therapy (DAPT) indication to address high bleeding risk (HBR) patients who are implanted with the Resolute Onyx Drug-Eluting Stent (DES). The Resolute Onyx DES is currently available for use in Europe and in countries recognizing the CE Mark.
Although the Resolute Onyx DES is currently available for use in the United States, it is not indicated for HBR patients with one-month DAPT. However, data have been submitted to the FDA to obtain a one-month DAPT US Indication for the product.
Armed with this milestone now, Medtronic aims to strengthen its Coronary and Renal Denervation business on a global scale. For investors’ note, the Coronary and Renal Denervation business is part of the company’s broader Cardiac and Vascular Group.
More on the Resolute Onyx
The indication received for the one-month DAPT indication for HBR patients with the Resolute Onyx DES is based on favorable study outcomes from the Onyx ONE Global Study. It was the first prospective and randomized one-month DAPT trial, conducted in approximately 2,000 HBR patients, which compared the Resolute Onyx to its competitor, BioFreedom DCS.
Per the study results, Resolute Onyx was no way inferior to BioFreedom DCS while meeting its primary composite endpoint of cardiac death, myocardial infarction or stent thrombosis at one-year. The study findings were presented during a late-breaking clinical trial session at a conference held in September 2019.
For investors’ note, the Onyx ONE Global Study and the Onyx ONE Clear Study (a study assessing Resolute Onyx DES in HBR patients with one-month DAPT in the United States and Japan) comprises the Medtronic Onyx ONE Month DAPT Program. The program has enrolled around 2,700 patients at up to 130 sites globally.
Significance of the Recognition
The longer DAPT treatments (which is a combination of aspirin and anti-clotting medication) may increase the risk of bleeding in the HBR patients. However, this latest and the only indication to date will enable physicians to recommend a shorter one-month regimen of DAPT after a percutaneous coronary intervention (PCI) with Resolute Onyx.
HBR patients, who are on longer DAPT routines, are three times more likely to experience bleeding events unlike the others undergoing PCI. However, the Resolute Onyx DES has proved through pre-clinical and clinical studies that owing to its design, it is suitable for patients who may be benefitted from a shorter DAPT duration.
Industry Prospects
Per a report by Reports and Data published on GlobeNewswire, the global DES market was valued at $5.63 billion in 2018 and is projected to reach $8.74 billion by 2026, witnessing a CAGR of approximately 5.7%. Factors like rise in the elderly population, growing prevalence of cardiovascular diseases and increasing acceptance of minimally-invasive endovascular surgeries are expected to drive the market.
Given the market potential, the receipt of the CE Mark bodes well for the company.
Recent Developments in Cardiac and Vascular Group
Of late, Medtronic has been witnessing a slew of developments in its business arm.
In May, the company announced the temporary use of its several cardiopulmonary technologies for Extracorporeal Membrane Oxygenation therapy spanning more than six hours in the United States, following the issuance of the FDA’s new guidelines released on Apr 6, 2020 in response to the coronavirus pandemic.
In the same month, the company announced the U.S. launch of Kyphon Assist Directional Cannula to be used with its balloon kyphoplasty products to treat vertebral compression fractures due to osteoporosis, cancer or benign lesions.
Last month, Medtronic announced results from two late-breaking clinical trials comprising 10-year outcomes from the Melody Transcatheter Pulmonary Valve (TPV) Therapy and the first-ever results from the investigational Harmony TPV pivotal trial. The company also posted data from late-breaking clinical trials assessing the MyCareLink Heart mobile app and the Micra Transcatheter Pacing System.
Price Performance
Shares of the company have gained 4.4% in the past year against the industry’s 0.2% fall. However, the stock has underperformed the S&P 500’s 10.5% rise.
Zacks Rank & Key Picks
Currently, Medtronic carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Aphria Inc. , Illumina, Inc. (ILMN - Free Report) and QIAGEN N.V. (QGEN - Free Report) .
Illumina’s long-term earnings growth rate is estimated at 11%. The company presently has a Zacks Rank #2.
QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Medtronic Resolute Onyx Gets CE Mark for 1-Month DAPT Therapy
Medtronic plc (MDT - Free Report) announced the receipt of the CE Mark for its one-month dual antiplatelet therapy (DAPT) indication to address high bleeding risk (HBR) patients who are implanted with the Resolute Onyx Drug-Eluting Stent (DES). The Resolute Onyx DES is currently available for use in Europe and in countries recognizing the CE Mark.
Although the Resolute Onyx DES is currently available for use in the United States, it is not indicated for HBR patients with one-month DAPT. However, data have been submitted to the FDA to obtain a one-month DAPT US Indication for the product.
Armed with this milestone now, Medtronic aims to strengthen its Coronary and Renal Denervation business on a global scale. For investors’ note, the Coronary and Renal Denervation business is part of the company’s broader Cardiac and Vascular Group.
More on the Resolute Onyx
The indication received for the one-month DAPT indication for HBR patients with the Resolute Onyx DES is based on favorable study outcomes from the Onyx ONE Global Study. It was the first prospective and randomized one-month DAPT trial, conducted in approximately 2,000 HBR patients, which compared the Resolute Onyx to its competitor, BioFreedom DCS.
Per the study results, Resolute Onyx was no way inferior to BioFreedom DCS while meeting its primary composite endpoint of cardiac death, myocardial infarction or stent thrombosis at one-year. The study findings were presented during a late-breaking clinical trial session at a conference held in September 2019.
For investors’ note, the Onyx ONE Global Study and the Onyx ONE Clear Study (a study assessing Resolute Onyx DES in HBR patients with one-month DAPT in the United States and Japan) comprises the Medtronic Onyx ONE Month DAPT Program. The program has enrolled around 2,700 patients at up to 130 sites globally.
Significance of the Recognition
The longer DAPT treatments (which is a combination of aspirin and anti-clotting medication) may increase the risk of bleeding in the HBR patients. However, this latest and the only indication to date will enable physicians to recommend a shorter one-month regimen of DAPT after a percutaneous coronary intervention (PCI) with Resolute Onyx.
HBR patients, who are on longer DAPT routines, are three times more likely to experience bleeding events unlike the others undergoing PCI. However, the Resolute Onyx DES has proved through pre-clinical and clinical studies that owing to its design, it is suitable for patients who may be benefitted from a shorter DAPT duration.
Industry Prospects
Per a report by Reports and Data published on GlobeNewswire, the global DES market was valued at $5.63 billion in 2018 and is projected to reach $8.74 billion by 2026, witnessing a CAGR of approximately 5.7%. Factors like rise in the elderly population, growing prevalence of cardiovascular diseases and increasing acceptance of minimally-invasive endovascular surgeries are expected to drive the market.
Given the market potential, the receipt of the CE Mark bodes well for the company.
Recent Developments in Cardiac and Vascular Group
Of late, Medtronic has been witnessing a slew of developments in its business arm.
In May, the company announced the temporary use of its several cardiopulmonary technologies for Extracorporeal Membrane Oxygenation therapy spanning more than six hours in the United States, following the issuance of the FDA’s new guidelines released on Apr 6, 2020 in response to the coronavirus pandemic.
In the same month, the company announced the U.S. launch of Kyphon Assist Directional Cannula to be used with its balloon kyphoplasty products to treat vertebral compression fractures due to osteoporosis, cancer or benign lesions.
Last month, Medtronic announced results from two late-breaking clinical trials comprising 10-year outcomes from the Melody Transcatheter Pulmonary Valve (TPV) Therapy and the first-ever results from the investigational Harmony TPV pivotal trial. The company also posted data from late-breaking clinical trials assessing the MyCareLink Heart mobile app and the Micra Transcatheter Pacing System.
Price Performance
Shares of the company have gained 4.4% in the past year against the industry’s 0.2% fall. However, the stock has underperformed the S&P 500’s 10.5% rise.
Zacks Rank & Key Picks
Currently, Medtronic carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Aphria Inc. , Illumina, Inc. (ILMN - Free Report) and QIAGEN N.V. (QGEN - Free Report) .
Aphria’s long-term earnings growth rate is projected at 24.6%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Illumina’s long-term earnings growth rate is estimated at 11%. The company presently has a Zacks Rank #2.
QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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