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ABIOMED Gets FDA Confirmation of the Safety of Impella RP

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ABIOMED, Inc. (ABMD - Free Report) recently announced that the FDA has validated the company’s Impella RP heart pump to be safe and effective for treatment of right heart failure. The FDA has emphasized on the utilization of early identification protocol, which will result in higher survival and native heart recovery.

ABIOMED’s foothold in the cardiovascular devices market is likely to be strengthened following the confirmation.

Additionally, the company recently released the new data from the National Cardiogenic Shock Initiative Study (NCSI) that shows that the protocol-based approach is capable of boosting survival rates in case of cardiogenic shock and is reproducible in academic and community hospitals across the United States. Here, NCSI protocol was utilized for treating patients, including placing of the Impella heart pump before revascularization.

Further Details on Impella RP

Notably, the Impella RP heart pump delivers blood from the inlet area, which sits in the inferior vena cava, through the cannula to the outlet opening near the tip of the catheter in the pulmonary artery.

The aforementioned validation followed after the FDA examined the results from Abiomed’s 18-month post-approval study (PAS) of 42 Impella RP patients. According to the data, 64% survival rate and 90% heart recovery has been witnessed for the subgroup of PAS patients who fulfilled the enrollment criteria of Impella RP’s premarket clinical studies.

Impella RP is the most studied right-sided device and the only percutaneous technology with FDA approval, hence the validation of being safe and effective for right heart support.

Impella Product Line at a Glance

Being ABIOMED’s flagship product line, Impella has been a consistent growth driver and is expected to boost results in the future as well.

Notably, worldwide Impella heart pump revenues in the reported quarter totaled $199.5 million, indicating an improvement of 19% from the year-ago quarter.

ABIOMED has been steadily investing to expand the platforms of Impella CP, Impella Connect, Impella 5.5 and Impella RP. The company has also announced a new technology, Impella Connect. This new platform has received CE Mark approval in Europe.

Recently, the company announced that its Impella CP with SmartAssist will be commercially available at the 2019 Society for Cardiovascular Angiography & Interventions (SCAI) Scientific Sessions. Additionally, majority of the Impella CP heart pumps will be transitioned to SmartAssist in fiscal 2020. (Read more: ABIOMED to Launch Impella CP With SmartAssist at SCAI).

Additionally, the company also announced the FDA approval for the expansion of its flagship Impella 5.0 and Impella LD for treating cardiogenic shock. Notably, this approval means that the duration of support for each Impella pump can be expanded from six to 14 days. (Read more: ABIOMED’s Impella 5.0 and LD Receive Expanded FDA Approvals).

Market Prospects

According to a report by The Business Research Company, the cardiovascular devices market is expected to reach a value of nearly $80.68 billion by 2022, at a CAGR of 5.7%. New health reforms, growing economy and rising awareness of healthcare fuel growth.

Zacks Rank and Price Performance

Currently, ABIOMED carries a Zacks Rank #4 (Sell). Shares of the company have lost 34.2%, compared with the industry’s decline of 3.3%. The current level also compares unfavorably with the S&P 500 Index’s growth of 4.1%.



Stocks that Warrant a Look

Some better-ranked stocks from the broader medical space are Cardiovascular Systems, Inc. (CSII - Free Report) , Quidel Corporation (QDEL - Free Report) and Heamonetics Corporation (HAE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Cardiovascular Systems has earnings growth rate for fiscal fourth quarter of 2019 of 33.3%.

Quidel Corporation has a long-term earnings growth rate of 25%.

Heamonetics has a long-term earnings growth rate 13.5%.

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