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Edwards Lifesciences' (EW) SAPIEN 3 With Alterra Gets FDA Nod
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Edwards Lifesciences (EW - Free Report) recently announced the receipt of the FDA’s approval for the SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for transcatheter pulmonic valve replacement. The recent development will fortify Edwards Lifesciences’ Transcatheter Aortic Valve Replacement segment.
Few Words on SAPIEN 3 with Alterra
The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (“TPV”) system with Alterra adaptive prestent is indicated for use in the management of pediatric and adult patients with extreme pulmonary regurgitation, who have surgically repaired right ventricular outflow tract and are clinically advised for surgical pulmonary valve replacement.
Image Source: Zacks Investment Research
The Edwards SAPIEN 3 TPV system has the proven SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent that increases transcatheter therapy options for congenital heart valve disease patients.
Significance of the SAPIEN 3 with Alterra
Per personnel associated with the SAPIEN 3 System clinical trial, the outcomes achieved by SAPIEN 3 with Alterra will extend the range of patients who require pulmonary valve replacement that can now be treated with minimally invasive therapy. This will result in considerable improvements in quality of life and reduce the number of surgeries.
Per Edwards Lifesciences’ management, many patients undergo repeated open-heart surgeries to tackle heart conditions present since birth, which make it difficult for them to lead normal lives. The SAPIEN 3 with Alterra offers a new treatment option that can reduce the number of invasive procedures patients face in their lifetimes.
Industry Prospects
Per Fortune Business Insights report, the global transcatheter heart valve replacement market was $4.04 billion in 2018 and is projected to reach $10.34 billion by 2026, at a CAGR of 12.5%. A rise in incidences of valvular heart diseases across the globe and the increasing demand for less-invasive procedures are the major factors driving the market.
Progress in TAVR Segment
The TAVR segment, during the third quarter, has performed well despite the pandemic-led business challenges. The segment registered 12% growth from the prior-year figure on a reported basis and 14% on an underlying basis. The growth was primarily driven by increased adoption of the company’s technologies, including the SAPIEN platform. Customer adoption for the SAPIEN 3 Ultra platform remains strong due to its low complication rates and easy-to-use design. During the third quarter, strong TAVR adoption continued in Japan. The company received reimbursement approval in the third quarter for the treatment of patients at low surgical risk. Notably, earlier in the second quarter, the company received approval for SAPIEN 3 to treat patients at low surgical risk.
Price Performance
Shares of the company have gained 36.4% in a year compared with the industry's rise of 6%.
Few better-ranked stocks from the broader medical space are Thermo Fisher Scientific Inc. (TMO - Free Report) , Laboratory Corporation of America Holdings (LH - Free Report) , or LabCorp and Medpace Holdings, Inc. (MEDP - Free Report) .
Thermo Fisher, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2021 adjusted earnings per share (EPS) of $5.76, which surpassed the Zacks Consensus Estimate by 23.3%. Revenues of $9.33 billion outpaced the Zacks Consensus Estimate by 12%.
Thermo Fisher has an estimated long-term growth rate of 14%. TMO surpassed estimates in the trailing four quarters, the average surprise being 9.02%.
LabCorp, carrying a Zacks Rank #1, reported third-quarter 2021 adjusted EPS of $6.82, which surpassed the Zacks Consensus Estimate by 42.9%. Revenues of $4.06 billion outpaced the Zacks Consensus Estimate by 13.4%.
LabCorp has an estimated long-term growth rate of 10.6%. LH surpassed estimates in the trailing four quarters, the average surprise being 25.7%.
Medpace reported third-quarter 2021 adjusted EPS of $1.29, surpassing the Zacks Consensus Estimate by 20.6%. Revenues of $295.57 million beat the Zacks Consensus Estimate by 1.2%.
Medpace has an estimated long-term growth rate of 16.4%. MEDP surpassed estimates in the trailing four quarters, the average surprise being 11.9%. It currently sports a Zacks Rank #2.
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Edwards Lifesciences' (EW) SAPIEN 3 With Alterra Gets FDA Nod
Edwards Lifesciences (EW - Free Report) recently announced the receipt of the FDA’s approval for the SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for transcatheter pulmonic valve replacement. The recent development will fortify Edwards Lifesciences’ Transcatheter Aortic Valve Replacement segment.
Few Words on SAPIEN 3 with Alterra
The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (“TPV”) system with Alterra adaptive prestent is indicated for use in the management of pediatric and adult patients with extreme pulmonary regurgitation, who have surgically repaired right ventricular outflow tract and are clinically advised for surgical pulmonary valve replacement.
Image Source: Zacks Investment Research
The Edwards SAPIEN 3 TPV system has the proven SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent that increases transcatheter therapy options for congenital heart valve disease patients.
Significance of the SAPIEN 3 with Alterra
Per personnel associated with the SAPIEN 3 System clinical trial, the outcomes achieved by SAPIEN 3 with Alterra will extend the range of patients who require pulmonary valve replacement that can now be treated with minimally invasive therapy. This will result in considerable improvements in quality of life and reduce the number of surgeries.
Per Edwards Lifesciences’ management, many patients undergo repeated open-heart surgeries to tackle heart conditions present since birth, which make it difficult for them to lead normal lives. The SAPIEN 3 with Alterra offers a new treatment option that can reduce the number of invasive procedures patients face in their lifetimes.
Industry Prospects
Per Fortune Business Insights report, the global transcatheter heart valve replacement market was $4.04 billion in 2018 and is projected to reach $10.34 billion by 2026, at a CAGR of 12.5%. A rise in incidences of valvular heart diseases across the globe and the increasing demand for less-invasive procedures are the major factors driving the market.
Progress in TAVR Segment
The TAVR segment, during the third quarter, has performed well despite the pandemic-led business challenges. The segment registered 12% growth from the prior-year figure on a reported basis and 14% on an underlying basis. The growth was primarily driven by increased adoption of the company’s technologies, including the SAPIEN platform. Customer adoption for the SAPIEN 3 Ultra platform remains strong due to its low complication rates and easy-to-use design. During the third quarter, strong TAVR adoption continued in Japan. The company received reimbursement approval in the third quarter for the treatment of patients at low surgical risk. Notably, earlier in the second quarter, the company received approval for SAPIEN 3 to treat patients at low surgical risk.
Price Performance
Shares of the company have gained 36.4% in a year compared with the industry's rise of 6%.
Zacks Rank and Key Picks
Edwards Lifesciences currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Few better-ranked stocks from the broader medical space are Thermo Fisher Scientific Inc. (TMO - Free Report) , Laboratory Corporation of America Holdings (LH - Free Report) , or LabCorp and Medpace Holdings, Inc. (MEDP - Free Report) .
Thermo Fisher, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2021 adjusted earnings per share (EPS) of $5.76, which surpassed the Zacks Consensus Estimate by 23.3%. Revenues of $9.33 billion outpaced the Zacks Consensus Estimate by 12%.
Thermo Fisher has an estimated long-term growth rate of 14%. TMO surpassed estimates in the trailing four quarters, the average surprise being 9.02%.
LabCorp, carrying a Zacks Rank #1, reported third-quarter 2021 adjusted EPS of $6.82, which surpassed the Zacks Consensus Estimate by 42.9%. Revenues of $4.06 billion outpaced the Zacks Consensus Estimate by 13.4%.
LabCorp has an estimated long-term growth rate of 10.6%. LH surpassed estimates in the trailing four quarters, the average surprise being 25.7%.
Medpace reported third-quarter 2021 adjusted EPS of $1.29, surpassing the Zacks Consensus Estimate by 20.6%. Revenues of $295.57 million beat the Zacks Consensus Estimate by 1.2%.
Medpace has an estimated long-term growth rate of 16.4%. MEDP surpassed estimates in the trailing four quarters, the average surprise being 11.9%. It currently sports a Zacks Rank #2.