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Abiomed's (ABMD) Impella ECP Gets FDA's Breakthrough Device Tag
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Abiomed, Inc. announced receipt of the FDA’s breakthrough device designation for its Impella ECP expandable percutaneous heart pump. Bestowing of the designation implies that the FDA will prioritize Impella ECP’s regulatory review processes, which include design iterations, clinical study protocols and pre-market approval (“PMA”) application.
For investors’ note, the Impella ECP is the smallest heart pump in the world and the first to be compatible with small bore access and closure techniques. However, it should be noted that the Impella ECP is limited to investigational use by federal law.
With the latest regulatory designation, Abiomed’s foothold is likely to be strengthened in the global coronary business.
Background of the Receipt
Impella ECP was granted the designation by the FDA partly on the back of favorable clinical data from the first 21 Impella ECP patients who were treated as part of an FDA-regulated early feasibility study. By granting the breakthrough device designation, the FDA has established that the Impella ECP meets its strict requirements to fall into said category.
Significance of the Receipt
Per estimates, around 440,000 patients are indicated and yet undertreated for high-risk percutaneous coronary interventions in the United States. Thus, Impella ECP’s size may help more physicians to offer critical hemodynamic support to coronary artery disease patients who require it.
Per management, granting of the breakthrough device designation acts as the FDA’s validation of the clinical benefits of Impella technology and its assertion of the innovative nature of Impella ECP, which has the potential to provide safer procedures and be available to a wider patient pool requiring hemodynamic support for coronary revascularization.
Industry Prospects
Per a report by Research and Markets, the global heart pump device market is anticipated to reach $5.5 billion by 2026 from $2.1 billion in 2021 at a CAGR of 21.6%. Factors like rising prevalence of cardiovascular diseases and long waiting periods for heart transplants are likely to drive the market.
Given the market potential, the FDA’s recognition is likely to provide a significant boost to Abiomed’s business globally.
Recent Developments
Of late, Abiomed has witnessed a few notable developments across its business.
The company, this month, reported robust first-quarter fiscal 2022 results where it saw strength in its global Impella revenues.
In June, Abiomed’s newest right heart pump Impella RP with SmartAssist received the FDA’s PMA as safe and effective to treat acute right heart failure for up to 14 days. The same month, the company acquired the remaining interest of preCARDIA, which will complement Abiomed’s product portfolio to expand options for upstream heart failure patients acutely decompensating.
Price Performance
Shares of the company have gained 6.7% in the past year compared with the industry’s 14.2% growth and the S&P 500's 32.8% rise.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Abiomed carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Henry Schein, Inc. (HSIC - Free Report) , IDEXX Laboratories, Inc. (IDXX - Free Report) and Intuitive Surgical, Inc. (ISRG - Free Report) .
Image: Bigstock
Abiomed's (ABMD) Impella ECP Gets FDA's Breakthrough Device Tag
Abiomed, Inc. announced receipt of the FDA’s breakthrough device designation for its Impella ECP expandable percutaneous heart pump. Bestowing of the designation implies that the FDA will prioritize Impella ECP’s regulatory review processes, which include design iterations, clinical study protocols and pre-market approval (“PMA”) application.
For investors’ note, the Impella ECP is the smallest heart pump in the world and the first to be compatible with small bore access and closure techniques. However, it should be noted that the Impella ECP is limited to investigational use by federal law.
With the latest regulatory designation, Abiomed’s foothold is likely to be strengthened in the global coronary business.
Background of the Receipt
Impella ECP was granted the designation by the FDA partly on the back of favorable clinical data from the first 21 Impella ECP patients who were treated as part of an FDA-regulated early feasibility study. By granting the breakthrough device designation, the FDA has established that the Impella ECP meets its strict requirements to fall into said category.
Significance of the Receipt
Per estimates, around 440,000 patients are indicated and yet undertreated for high-risk percutaneous coronary interventions in the United States. Thus, Impella ECP’s size may help more physicians to offer critical hemodynamic support to coronary artery disease patients who require it.
Per management, granting of the breakthrough device designation acts as the FDA’s validation of the clinical benefits of Impella technology and its assertion of the innovative nature of Impella ECP, which has the potential to provide safer procedures and be available to a wider patient pool requiring hemodynamic support for coronary revascularization.
Industry Prospects
Per a report by Research and Markets, the global heart pump device market is anticipated to reach $5.5 billion by 2026 from $2.1 billion in 2021 at a CAGR of 21.6%. Factors like rising prevalence of cardiovascular diseases and long waiting periods for heart transplants are likely to drive the market.
Given the market potential, the FDA’s recognition is likely to provide a significant boost to Abiomed’s business globally.
Recent Developments
Of late, Abiomed has witnessed a few notable developments across its business.
The company, this month, reported robust first-quarter fiscal 2022 results where it saw strength in its global Impella revenues.
In June, Abiomed’s newest right heart pump Impella RP with SmartAssist received the FDA’s PMA as safe and effective to treat acute right heart failure for up to 14 days. The same month, the company acquired the remaining interest of preCARDIA, which will complement Abiomed’s product portfolio to expand options for upstream heart failure patients acutely decompensating.
Price Performance
Shares of the company have gained 6.7% in the past year compared with the industry’s 14.2% growth and the S&P 500's 32.8% rise.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Abiomed carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Henry Schein, Inc. (HSIC - Free Report) , IDEXX Laboratories, Inc. (IDXX - Free Report) and Intuitive Surgical, Inc. (ISRG - Free Report) .
Henry Schein’s long-term earnings growth rate is estimated at 13.9%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
IDEXX’s long-term earnings growth rate is estimated at 19.9%. It currently has a Zacks Rank #2.
Intuitive Surgical’s long-term earnings growth rate is estimated at 9.7%. It currently carries a Zacks Rank #2.