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Medtronic's (MDT) Symplicity Spyral RDN System Gets FDA Boost
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Medtronic plc (MDT - Free Report) gained FDA approval for its Symplicity Spyral renal denervation (RDN) system, also known as the Symplicity blood pressure procedure, for the treatment of hypertension. Following this win, the commercialization of the therapy will begin immediately.
The latest development represents a milestone for physicians and patients in the treatment of hypertension. The approval, which is a culmination of ten years of clinical research and development of the Medtronic renal denervation technology, will boost the company’s Cardiovascular portfolio.
Significance of the News
Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke and death, and its prevalence is notably worse among the underserved communities in the United States. Despite the available medications and lifestyle interventions, control rates remain low. These challenges boast the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure.
Image Source: Zacks Investment Research
For Medtronic, the potential of this therapy has led to forming close partnerships with leading experts in the clinical community who could help deliver this technology to the people who need it most. According to the company’s representative, the promise of this therapy enabled Medtronic to keep going, even when others exited the renal denervation space.
News in Detail
The Medtronic Symplicity blood pressure procedure is innovative and minimally invasive, delivering radiofrequency to nerves near kidneys that can become overactive and contribute to high blood pressure. After sedation, doctors insert a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, doctors administer energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.
Patient preference and shared decision-making have been identified as critical components of developing a hypertension care plan, including the Symplicity blood pressure procedure. The results from a Medtronic-led patient preference study demonstrated that one-third of patients were likely to choose the interventional treatment when presented with an interventional treatment with blood pressure reduction and potential risks in line with those of the Symplicity blood pressure procedure.
Industry Prospects
Per a Research report, the hypertension drug market was valued at $31.76 billion in 2022 and is expected to witness a CAGR of 4.0% by 2030.
Notable Highlights in the Cardiovascular Space
Last month, Medtronic received the FDA approval for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. The approval was supported by global pivotal trial results showing the system's safety and effectiveness, which were published in The New England Journal of Medicine.
In the same month, the company announced four-year results from the Evolut Low Risk Trial, wherein the Medtronic Evolut transcatheter aortic valve replacement (TAVR) system demonstrated exceptional outcomes and sustained valve performance, proven by significantly better hemodynamics than surgical aortic valve replacement (SAVR). The data were presented at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference and simultaneously published in the Journal of the American College of Cardiology.
Price Performance
In the past six months, MDT shares have lost 16.4% compared with the industry’s decline of 14.7%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
Haemonetics’ stock has risen 2.8% in the past year. Earnings estimates for Haemonetics have increased from $3.82 to $3.86 in 2023 and $4.07 to $4.11 in 2024 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for Insulet’s 2023 earnings per share have increased from $1.61 to $1.90 in the past 30 days. Shares of the company have lost 40.1% in the past year compared with the industry’s decline of 6.3%.
PODD’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 105.1%. In the last reported quarter, it delivered an average earnings surprise of 77.4%.
Estimates for DexCom’s 2023 earnings per share have increased from $1.23 to $1.43 in the past 30 days. Shares of the company have fallen 6.8% in the past year compared with the industry’s decline of 6.6%.
DXCM’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 36.4%. In the last reported quarter, it delivered an average earnings surprise of 47.1%.
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Medtronic's (MDT) Symplicity Spyral RDN System Gets FDA Boost
Medtronic plc (MDT - Free Report) gained FDA approval for its Symplicity Spyral renal denervation (RDN) system, also known as the Symplicity blood pressure procedure, for the treatment of hypertension. Following this win, the commercialization of the therapy will begin immediately.
The latest development represents a milestone for physicians and patients in the treatment of hypertension. The approval, which is a culmination of ten years of clinical research and development of the Medtronic renal denervation technology, will boost the company’s Cardiovascular portfolio.
Significance of the News
Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke and death, and its prevalence is notably worse among the underserved communities in the United States. Despite the available medications and lifestyle interventions, control rates remain low. These challenges boast the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure.
Image Source: Zacks Investment Research
For Medtronic, the potential of this therapy has led to forming close partnerships with leading experts in the clinical community who could help deliver this technology to the people who need it most. According to the company’s representative, the promise of this therapy enabled Medtronic to keep going, even when others exited the renal denervation space.
News in Detail
The Medtronic Symplicity blood pressure procedure is innovative and minimally invasive, delivering radiofrequency to nerves near kidneys that can become overactive and contribute to high blood pressure. After sedation, doctors insert a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, doctors administer energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.
Patient preference and shared decision-making have been identified as critical components of developing a hypertension care plan, including the Symplicity blood pressure procedure. The results from a Medtronic-led patient preference study demonstrated that one-third of patients were likely to choose the interventional treatment when presented with an interventional treatment with blood pressure reduction and potential risks in line with those of the Symplicity blood pressure procedure.
Industry Prospects
Per a Research report, the hypertension drug market was valued at $31.76 billion in 2022 and is expected to witness a CAGR of 4.0% by 2030.
Notable Highlights in the Cardiovascular Space
Last month, Medtronic received the FDA approval for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. The approval was supported by global pivotal trial results showing the system's safety and effectiveness, which were published in The New England Journal of Medicine.
In the same month, the company announced four-year results from the Evolut Low Risk Trial, wherein the Medtronic Evolut transcatheter aortic valve replacement (TAVR) system demonstrated exceptional outcomes and sustained valve performance, proven by significantly better hemodynamics than surgical aortic valve replacement (SAVR). The data were presented at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference and simultaneously published in the Journal of the American College of Cardiology.
Price Performance
In the past six months, MDT shares have lost 16.4% compared with the industry’s decline of 14.7%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics (HAE - Free Report) , Insulet (PODD - Free Report) and DexCom (DXCM - Free Report) . Haemonetics and DexCom each presently carry a Zacks Rank #2 (Buy), and Insulet sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Haemonetics’ stock has risen 2.8% in the past year. Earnings estimates for Haemonetics have increased from $3.82 to $3.86 in 2023 and $4.07 to $4.11 in 2024 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for Insulet’s 2023 earnings per share have increased from $1.61 to $1.90 in the past 30 days. Shares of the company have lost 40.1% in the past year compared with the industry’s decline of 6.3%.
PODD’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 105.1%. In the last reported quarter, it delivered an average earnings surprise of 77.4%.
Estimates for DexCom’s 2023 earnings per share have increased from $1.23 to $1.43 in the past 30 days. Shares of the company have fallen 6.8% in the past year compared with the industry’s decline of 6.6%.
DXCM’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 36.4%. In the last reported quarter, it delivered an average earnings surprise of 47.1%.