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Abiomed Gets FDA Nod for Data Streaming Via Impella Connect

Abiomed, Inc. ABMD recently announced that the FDA has approved one-way digital data streaming with respect to patient support from its Automated Impella Controller (AIC), which is the external console utilized with Impella heart pumps. The approval implies that console data can now be streamed live through Impella Connect to a secure server where artificial intelligence (AI) can aid the patient’s clinician with predictive clinical information.

The approval is likely to strengthen Abiomed’s robust and extensive Impella product line further.

Notably, Impella is Abiomed’s flagship product line that continues to be a key catalyst. Moreover, Impella is the world's smallest heart pump. It is a support system of percutaneous, catheter-based devices offering hemodynamic support to the heart.

Impella Connect at a Glance

Impella Connect allows hospital clinicians and staff, and Abiomed’s Clinical Support Team to view the AIC screen through a secure website, which helps them to track, review and share that information from any internet-enabled phone, tablet or computer.

Importance of Artificial Intelligence in Impella Heart Pumps

It is important to note here that the data streaming ability is facilitated through the Impella Connect interface, a HIPAA-compliant, a cloud-based remote monitoring platform, which is presently installed at more than 200 hospitals.

In order to demonstrate how this technology can be used in future clinical practice, Abiomed has already developed an AI algorithm to predict the next five minutes of a patient’s arterial pressure on the basis of the prior five minutes of console data. Further, the company has developed AI algorithms to predict other parameters like stroke volume, left ventricular pressure and cardiac output.



Notably, the AI algorithms have not yet been cleared or approved for patient use. The AI algorithms will be submitted for regulatory review once they are fully developed.

Properly trained AI networks, which can utilize large volumes of streaming data, can become powerful tools, which will aid in clinical decision-making.
Hence, the approval is significant in making clinical decision-making more efficient, thereby further boosting patient outcomes.

Recent Developments

In June, the company launched a revolutionary digital education platform called CAMP PCI, which stands for Coronary Artery & Myocardial Protected Percutaneous Coronary Intervention. It is designed to enhance patient outcomes and quality of life with supported high-risk PCI by using the best practices, techniques and technologies to enable safer, more efficient and complete revascularization.

In the same month, the company 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.

Market Prospects

Per a report by Grand View Research, the global cardiovascular devices market is anticipated to see a CAGR of 6.6% over the forecast period (2016-2024). The rising prevalence of chronic heart diseases and sedentary lifestyles are key factors driving this market.

Hence, the approval comes at an opportune time for Abiomed.

Price Performance

Over the past year, shares of this Zacks Rank #4 (Sell) company have gained 7.8% compared with the industry’s growth of 13.7%.

Stocks to Consider

Some better-ranked stocks from the broader medical space include Quest Diagnostics Incorporated DGX, West Pharmaceutical Services, Inc. WST and Laboratory Corporation of America Holdings LH. While Quest Diagnostics and Laboratory Corporation sport a Zacks Rank #1 (Strong Buy), West Pharmaceutical carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Quest Diagnostics has an estimated long-term earnings growth rate of 13.2%.

Laboratory Corporation has an estimated long-term earnings growth rate of 7.5%.

West Pharmaceutical has a projected long-term earnings growth rate of 9.2%.

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