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ABIOMED Gets FDA Nod for First-in-Human Trial of Impella ECP
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ABIOMED, Inc recently announced that the FDA has approved investigational device exemption application to initiate an early feasibility study with a first-in-human trial of the company’s 9 French (Fr) Impella ECP heart pump. The Impella ECP, which stands for expandable cardiac power, will be assessed in high-risk percutaneous coronary intervention (PCI) patients.
Being the world’s smallest heart pump, Impella ECP has been designed for short-term mechanical support in patients undergoing a high-risk PCI. It provides both circulatory support and left ventricular unloading.
More on the Device
With respect to interventional cardiologists, vascular access and closure are instrumental to the success of PCI procedures with mechanical circulatory support. Usually, these procedures require placement of sheaths or cannulas ranging from 13-24 Fr to perform the intervention. Impella ECP enables a smaller access site, which may enhance adoption.
This prospective, multi-center, non-randomized early feasibility study will enable ABIOMED, the study investigators and the FDA to make qualitative evaluation about the safety and viability of Impella ECP use in high-risk patients. The primary goal of the study is successful delivery, initiation and maintenance of sufficient hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI. Per the study protocol, around five U.S. patients who require revascularization will be enrolled. If successful, enrollment will be increased on FDA approval. Patient enrollment is slated to begin later in 2020 for the first-in-human trial.
For investors’ notice, Impella ECP is available for investigational use only.
Market Prospects
Per areport byGrand View Research, the global ventricular assist device market size was valued at $1.7 billion in 2019 and is expected to see a CAGR of 11.7% from 2020 to 2027. Hence, this FDA approval comes at an ideal time.
Recent Developments
In June 2020, ABIOMED’s Impella RP attained the FDA’s Emergency Use Authorization (EUA) for treating COVID-19-related right heart failure or decompensation, including PE.
In May 2020, data from more than 1,000 patients highlighted that Impella can significantly diminish in-hospital mortality when placed before a non-emergent PCI is performed.
Price Performance
In the past three months, the stock has gained 59.8% compared with 8.3% growth of its industry.
Aphria’s long-term earnings growth rate is estimated at 24.6%. The company presently carries a Zacks Rank #2 (Buy).
DexCom’s long-term earnings growth rate is estimated at 36.3%. The company presently carries a Zacks Rank #2.
HMS Holdings’ long-term earnings growth rate is estimated at 10%. It currently carries a Zacks Rank #2.
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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ABIOMED Gets FDA Nod for First-in-Human Trial of Impella ECP
ABIOMED, Inc recently announced that the FDA has approved investigational device exemption application to initiate an early feasibility study with a first-in-human trial of the company’s 9 French (Fr) Impella ECP heart pump. The Impella ECP, which stands for expandable cardiac power, will be assessed in high-risk percutaneous coronary intervention (PCI) patients.
Being the world’s smallest heart pump, Impella ECP has been designed for short-term mechanical support in patients undergoing a high-risk PCI. It provides both circulatory support and left ventricular unloading.
More on the Device
With respect to interventional cardiologists, vascular access and closure are instrumental to the success of PCI procedures with mechanical circulatory support. Usually, these procedures require placement of sheaths or cannulas ranging from 13-24 Fr to perform the intervention. Impella ECP enables a smaller access site, which may enhance adoption.
This prospective, multi-center, non-randomized early feasibility study will enable ABIOMED, the study investigators and the FDA to make qualitative evaluation about the safety and viability of Impella ECP use in high-risk patients. The primary goal of the study is successful delivery, initiation and maintenance of sufficient hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI. Per the study protocol, around five U.S. patients who require revascularization will be enrolled. If successful, enrollment will be increased on FDA approval. Patient enrollment is slated to begin later in 2020 for the first-in-human trial.
For investors’ notice, Impella ECP is available for investigational use only.
Market Prospects
Per a report by Grand View Research, the global ventricular assist device market size was valued at $1.7 billion in 2019 and is expected to see a CAGR of 11.7% from 2020 to 2027. Hence, this FDA approval comes at an ideal time.
Recent Developments
In June 2020, ABIOMED’s Impella RP attained the FDA’s Emergency Use Authorization (EUA) for treating COVID-19-related right heart failure or decompensation, including PE.
In May 2020, data from more than 1,000 patients highlighted that Impella can significantly diminish in-hospital mortality when placed before a non-emergent PCI is performed.
Price Performance
In the past three months, the stock has gained 59.8% compared with 8.3% growth of its industry.
Zacks Rank and Key Picks
ABIOMED currently has a Zacks Rank#3 (Hold).
Some better-ranked stocks from the broader medical space are Aphria , DexCom (DXCM - Free Report) and HMS Holdings .You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aphria’s long-term earnings growth rate is estimated at 24.6%. The company presently carries a Zacks Rank #2 (Buy).
DexCom’s long-term earnings growth rate is estimated at 36.3%. The company presently carries a Zacks Rank #2.
HMS Holdings’ long-term earnings growth rate is estimated at 10%. It currently carries a Zacks Rank #2.
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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