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Abiomed's (ABMD) Impella RP With SmartAssist Gets FDA Nod

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Abiomed, Inc. ABMD recently received FDA pre-market approval (PMA) for its newest right heart pump — the Impella RP with SmartAssist. The FDA has deemed the new pump as safe and effective when it comes to treatment of right heart failure for up to 14 days.

It is worth mentioning that Impella RP with SmartAssist is an innovative advancement of Impella RP (granted a PMA by the FDA in 2017). Moreover, in last June, the FDA issued an emergency use authorization (EUA) for Impella RP for the purpose of treating patients suffering from COVID-19 associated right heart failure or decompensation, including pulmonary embolism (PE).

This announcement is likely to provide a substantial boost to Abiomed’s Impella product portfolio.

Impella RP With SmartAssist at a Glance

As the first dual-sensor technology heart pump, it offers real-time guidance and aids with pump management and weaning. In fact, the pump has been created for a simple setup and insertion. It has been improved with Impella Connect to help in remote monitoring from any internet-connected device through a secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant website.

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Notably, SmartAssist technology is also available on Impella CP and Impella 5.5 with respect to management of left heart failure and early detection of right heart failure.

More on the News

According to physicians in the cardiology space, the addition of SmartAssist technology to Impella RP is an important step forward to help them in achieving improved patient outcomes with an enhanced design and intuitive metrics.

When it comes to improving patient survival rates, early identification of right heart failure along with early action is extremely important. Per data, Impella RP aids in improving survival rates greatly with respect to critically ill patients who require right heart hemodynamic support.

Market Prospects

Per a report by MarketsandMarkets, the global hemodynamic monitoring systems market is projected to reach $1.17 billion by 2023 from an estimated $857.8 million in 2018, witnessing a CAGR of 6.4%. Technological advancements in hemodynamic monitoring systems, growing research into these systems, increasing prevalence of cardiovascular diseases and diabetes are some of the factors driving this market’s growth.

Hence, this PMA from the FDA comes at an opportune time for Abiomed.

Recent Developments

This month, the company announced its buyout of preCARDIA to enhance treatment for patients with acute decompensated heart failure (“ADHF”). The acquisition of preCARDIA, a developer of a proprietary catheter and controller, is expected to complement Abiomed’s product portfolio for better patient outcomes.

In April, Abiomed announced the final results of the physician-led National Cardiogenic Shock Initiative (NCSI) Study. The results demonstrated a significant survival to discharge with greater than 90% native heart recovery when best practices are used, including placement of an Impella heart pump prior to revascularization.

Price Performance

Shares of the Zacks Rank #4 (Sell) company have gained 22.8% in the past year compared with the industry’s growth of 21.1%.

Stocks to Consider

Some better-ranked stocks from the broader medical space are Veeva Systems Inc. VEEV, DaVita Inc. DVA and Baxter International Inc. BAX, each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Veeva Systems’ long-term earnings growth rate is estimated at 15.8%.

DaVita’s long-term earnings growth rate is estimated at 14.4%.

Baxter International’s long-term earnings growth rate is projected at 9.3%.

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