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Edwards Lifesciences' SAPIEN 3 THV Cleared for Use in China
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Edwards Lifesciences Corporation (EW - Free Report) recently announced the receipt of China’s regulatory approval for its SAPIEN 3 transcatheter heart valve (THV). The approval is particularly for treating patients suffering from severe symptomatic aortic stenosis (AS) who are at higher risks for or unable to undergo open-heart surgery.
The SAPIEN 3 THV consists of a catheter-based artificial heart valve and accessories used to implant the valve without open-heart surgery.
To date, more than 30,000 patients in around 65 countries have been treated in clinical trials and registries, making the SAPIEN TAVR valves the most widely-studied transcatheter valves.
With the latest regulatory approval, Edwards Lifesciences aims to strengthen foothold in the global Transcatheter Aortic Valve Replacement (TAVR) business.
Significance of the Approval
Per the medical fraternity in China, the availability of a shorter procedure with favorable clinical outcomes (including a faster recovery unlike open-heart surgery) for patients with severe AS will be a much-needed option.
The approval for use of SAPIEN 3 THV in high-risk and extreme-risk patients in China was supported by the China SAPIEN 3 study. The said study complements a highly robust set of clinical results from three randomized controlled PARTNER studies along with favorable real-world outcomes.
Edwards Lifesciences’s management is eyeing partnerships with hospitals across China to introduce the therapy.
Industry Prospects
Per a report by Research And Markets, the global TAVR market is projected to see a CAGR of approximately 12.7% to reach $7.78 billion from 2020 to 2024. Factors like rising prevalence of AS and increasing preference of minimally-invasive surgeries are expected to drive the market.
Given the market potential, the approval seems well-timed.
Recent Developments in TAVR Arm
Of late, Edwards Lifesciences has been witnessing a slew of developments in its business arm.
The company, in May, received CE Mark for its PASCAL transcatheter valve repair system, which is to be used for the treatment of patients with tricuspid regurgitation in Europe.
In April, during its first-quarter 2020 earnings call, Edwards Lifesciences stated that its global TAVR segment recorded strong underlying growth despite the pandemic-led business disruptions. The company also stated that its U.S. TAVR sales growth was robust, which primarily resulted from the inclusion of new patients through early March. TAVR adoption was strong in Japan in the first quarter.
Further during the call, the company confirmed that the rollout of the SAPIEN 3 Ultra was positive and clinician feedback on improved paravalvular leak performance was favorable. However, due to the pandemic, the rollout had to be discontinued and is expected to resume soon.
Price Performance
Shares of the company have gained 24.6% in the past year compared with the industry’s 8.8% growth and the S&P 500’s 11.8% rise.
Zacks Rank & Key Picks
Currently, Edwards Lifesciences 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.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
Image: Bigstock
Edwards Lifesciences' SAPIEN 3 THV Cleared for Use in China
Edwards Lifesciences Corporation (EW - Free Report) recently announced the receipt of China’s regulatory approval for its SAPIEN 3 transcatheter heart valve (THV). The approval is particularly for treating patients suffering from severe symptomatic aortic stenosis (AS) who are at higher risks for or unable to undergo open-heart surgery.
The SAPIEN 3 THV consists of a catheter-based artificial heart valve and accessories used to implant the valve without open-heart surgery.
To date, more than 30,000 patients in around 65 countries have been treated in clinical trials and registries, making the SAPIEN TAVR valves the most widely-studied transcatheter valves.
With the latest regulatory approval, Edwards Lifesciences aims to strengthen foothold in the global Transcatheter Aortic Valve Replacement (TAVR) business.
Significance of the Approval
Per the medical fraternity in China, the availability of a shorter procedure with favorable clinical outcomes (including a faster recovery unlike open-heart surgery) for patients with severe AS will be a much-needed option.
The approval for use of SAPIEN 3 THV in high-risk and extreme-risk patients in China was supported by the China SAPIEN 3 study. The said study complements a highly robust set of clinical results from three randomized controlled PARTNER studies along with favorable real-world outcomes.
Edwards Lifesciences’s management is eyeing partnerships with hospitals across China to introduce the therapy.
Industry Prospects
Per a report by Research And Markets, the global TAVR market is projected to see a CAGR of approximately 12.7% to reach $7.78 billion from 2020 to 2024. Factors like rising prevalence of AS and increasing preference of minimally-invasive surgeries are expected to drive the market.
Given the market potential, the approval seems well-timed.
Recent Developments in TAVR Arm
Of late, Edwards Lifesciences has been witnessing a slew of developments in its business arm.
The company, in May, received CE Mark for its PASCAL transcatheter valve repair system, which is to be used for the treatment of patients with tricuspid regurgitation in Europe.
In April, during its first-quarter 2020 earnings call, Edwards Lifesciences stated that its global TAVR segment recorded strong underlying growth despite the pandemic-led business disruptions. The company also stated that its U.S. TAVR sales growth was robust, which primarily resulted from the inclusion of new patients through early March. TAVR adoption was strong in Japan in the first quarter.
Further during the call, the company confirmed that the rollout of the SAPIEN 3 Ultra was positive and clinician feedback on improved paravalvular leak performance was favorable. However, due to the pandemic, the rollout had to be discontinued and is expected to resume soon.
Price Performance
Shares of the company have gained 24.6% in the past year compared with the industry’s 8.8% growth and the S&P 500’s 11.8% rise.
Zacks Rank & Key Picks
Currently, Edwards Lifesciences 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.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>