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Abiomed Gets CDSCO Nod for Impella Heart Pumps in India

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Abiomed Gets CDSCO Nod for Impella Heart Pumps in India

Abiomed's (ABMD) Impella gets regulatory approval in India; prospects in APAC look upbeat.

Abiomed, Inc. ABMD recently received the Central Drugs Standard Control Organization (CDSCO) approval in India for its flagship Impella 2.5, Impella CP and Impella 5.0 heart pumps. Notably, this fortifies the company’s position in the Asia-Pacific (APAC) zone.

Additionally, the Impella 2.5 heart pump successfully treated the first patient at Fortis Escorts Heart Institute in New Delhi. In the past, the Office of the Drug Controller General (DCGI) in India had granted registration for Abiomed’s Impella 2.5 and Impella 5.0 heart pumps.

Going by an article published in the Times of India, death from heart diseases in India has risen 34% in the past 26 years. Per Transparency Market Research, the cardiology devices market in the APAC region is expected to witness the fastest rate of growth. According to the study, the market is expected to see a CAGR of 2.9% to reach an estimated value of $11.2 billion in 2022.

Hence, the latest development is likely to be a strategic one for the Massachusetts-based developer of cardiac devices.

Impella in Focus

Abiomed’s recently reported fiscal first-quarter 2019 results saw a strong performance by the exclusive Impella product line.

Per management, Impella contributed $2.6 million to the quarter’s revenues. U.S. revenues were driven by strong Impella adoption in the Protected PCI (Percutaneous Coronary Intervention) and cardiogenic shock indications, which grew 24% and 37%, respectively.

European revenues increased 53% year over year. Furthermore, Impella grew favorably in Japan in the quarter.

Other MedTech Bigwigs in APAC

Some of the U.S. MedTech bigwigs have already carved out a niche in the APAC region.

Baxter International BAX has a solid presence in Asia, with research hubs in Japan and China. The company’s renal care team recently launched KAGUYA peritoneal dialysis technology in Japan. The company’s sales in the APAC region rose 6% at constant currency in the recently reported second quarter of 2018.

Intuitive Surgical’s ISRG flagship da Vinci in general surgery and urology procedures have been witnessing consistent growth in Asia. Earlier this year, California-based manufacturer of surgical systems announced the start of operations in India through its distributor Vattikuti Technologies Pvt. Ltd. (Read more: Intuitive Surgical Commences Direct Operations in India)

Price Performance

In the past year, shares of Baxter, a Zacks Rank #2 (Buy) company have skyrocketed 149.3% against the industry’s decline of 7.9%.

Want More From the Industry?

Another top-ranked stock from the Medical Instruments industry is Masimo Corporation MASI.

Masimo carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. In the recent past, the company announced that NU Hospitals, a leading nephrology care center in India, has standardized on Masimo technologies across the continuum of care.

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