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CMS rate cuts for Abiomed Impella not as bad as expected

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]

CMS will pay 11% less for the tiny Impella heart pump made by Abiomed (NSDQ:ABMD) during the upcoming federal fiscal year — but the reduction is better than the 24% cut originally proposed.

For the federal fiscal year ended Sept. 30, 2021, the rate for uni-ventricular Impella percutaneous insertion will be $71,950, down from the previous $80,650.

Analysts at Jefferies in a note today said they expect the impact on utilization to be minimal.

CMS acknowledged the magnitude of the cut it originally proposed, according to the Jefferies analysts. They added that the largest healthcare payer in the U.S. is looking at fixes going forward to stabilize Impella reimbursement.

ABMD shares are down 4.5% to $298.73 apiece in morning trading today. MassDevice’s MedTech 100 Index, which includes …

Medtech stocks help boost S&P rally

Medtech stocks helped the S&P 500 Index reach record highs today amid a bounceback from the lows of the COVID-19 pandemic.

Reuters reported that medtech played its part in the record turn of the market, with Abiomed (NSDQ:ABMD), Regeneron Pharmaceuticals (NSDQ:REGN) and West Pharmaceutical Services (NYSE:WST), all of which are involved in developing COVID-19 therapeutics, all rising more than 50% since the index’s previous record high before the pandemic in February.

The report attributed the S&P’s rise in part to the economic stimulus in response to the pandemic, as the index has risen more than 50% from its low on March 23 and is up nearly 5% for the year so far.

Currently, the S&P 500 is up 0.2% for the day at 3,389.78 points.

Medtech’s part in the S&P 500’s rise falls in line with the performance of MassDevice’s MedTech 100 Index, which includes stocks of the world’s largest medical device co…

MedTech 100 roundup: Another high as stocks tick up

For the third consecutive week, stocks in the medtech industry reached heights not yet seen since the COVID-19 pandemic began.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.65 points at the end of last week (Aug. 7). Overall, medtech stocks saw a 0.72% increase from the 89.01-point total at the same time a week prior (July 31).

On Aug. 5, the index reached 90.45 points, marking its highest point since that pre-pandemic high, with the previous mid-pandemic high (90.37) coming last week.

The most recent high mark represents just a -2% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Meanwhile, the S&P 500 Index saw a 2.5% increase from July 31 to Aug. 7, and the Dow Jones Index fared even better, positng a 3.8% rise over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13…

Abiomed shares slide on Street-beating Q1 results

Abiomed (NSDQ:ABMD) posted first-quarter results today that beat the consensus on Wall Street.

The Danvers, Mass.-based company reported profits of $44.6 million, or 98¢ per share, on sales of $164.9 million for the three months ended June 30, for a bottom-line loss of -95% sales loss of -20.6% compared with Q1 2019.

Adjusted to exclude one time items, earnings per share were 58¢, 26¢ ahead of The Street, where analysts were looking for sales of $144.1 million.

“I am proud of Abiomed’s execution during the COVID-19 pandemic, delivering on our Q1 RED phase commitments and maintaining our focus to recover hearts and save lives. We achieved sequential improvements in revenue and patients, strengthened our clinical data, and advanced our pipeline technology,” president and CEO Michael Minogue said in a news release. “We will make fiscal year 2021 one of the most productive and transformative years for the company as we build Abiomed 2.0 and continue to innov…

FDA issues EUA for Abiomed Impella heart pumps for COVID-19 therapy

Abiomed (NSDQ:ABMD) announced today that the FDA issued emergency use authorization (EUA) for its Impella heart pumps in COVID-19 therapy.

The EUA covers the left-sided Impella pumps in providing left ventricular unloading, supporting COVID-19 patients who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and develop pulmonary edema or myocarditis, according to a news release.

Impella, the world’s smallest heart pump, combined with ECMO therapy (Abiomed’s therapy is called ECpella) helps to treat COVID-19 patients suffering from both heart and lung failure due to the virus’ capabilities of causing widespread inflammation that damages the heart and lungs.

“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” University of Pennsylvania professor of surgery & surgical director of lung transplantation & ECMO Dr. Christian Bermudez said in the re…

Abiomed touts results of U.S. study of its latest Impella heart pump

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]

Abiomed (NSDQ:ABMD) says a study of U.S. patients receiving the new Impella 5.5 with SmartAssist found that 84% survived to explant and 76% experienced native heart recovery.

The study — published in the July edition of the American Society for Artificial Internal Organs (ASAIO) Journal — examined the outcomes of the first 55 patients treated with Impella 5.5 with SmartAssist at Cleveland Clinic, Hackensack University Medical Center/Hackensack Meridian Health and Cedars-Sinai Medical Center.

Study authors and cardiac surgeons Drs. Ed Soltesz, Mark Andersonv and Danny Ramzy cautioned that the study represented an early experience in a heterogeneous patient population, but they still found the results encouraging. They deemed the Impella 5.5 with SmartAssist to be safe and effective for a number of chal…

Abiomed appoints new chief medical officer

Abiomed (NSDQ:ABMD) today said it appointed Charles Simonton as VP and chief medical officer.

Simonton most recently served as chief medical officer and divisional VP of global medical affairs at Abbott Vascular where he led programs that resulted in FDA approval of carotid stents, MitraClip and Absorb BVS. He has also spent almost 30 years as an interventional cardiologists working with complex cardiac and vascular patients.

“I am excited to be a part of Abiomed’s dedicated team focused on developing innovative medical devices. Over the years, I have become very familiar with the benefits of Impella and its ability to unload the heart and have seen how it is transforming the standard of care. I am impressed with Abiomed’s talent, culture, and mission and I am thrilled to be joining the company,” Simonton said in a news release.

Simonton replaces Seth Bilazarian who served as VP and chief medical officer since 2015. Bilazarian will assume medical leaders…

FDA approves Abiomed’s Impella ECP clinical trial

Abiomed (NSDQ:ABMD) announced today that it received FDA investigational device exemption approval to begin a clinical trial for the Impella ECP heart pump.

Impella ECP (expendable cardiac power) will be studied in the early feasibility, first-in-human trial for high-risk percutaneous coronary intervention (PCI) patients, according to a news release.

The prospective, multi-center, non-randomized trial will assess the safety and feasibility of the device with a primary endpoint of successful delivery, initiation and maintenance of adequate hemodynamic support. It will enroll and treat up to five U.S. patients who require revascularization and will expand to additional patients (pending FDA approval) if it is successful. Enrollment will begin later this year.

Danvers, Mass.-based Abiomed touts its Impella ECP as the world’s smallest heart pump with peak flows greater than 3.5 L per minute, delivered through a slender-profile sheath. Using a specially…

FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure

Abiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for use with COVID-19-related right heart failure.

The Impella RP temporary heart pump provides circulatory support for patients with right side ventricular failure. It won FDA approval in September 2017 for such an indication and in October 2019 Abiomed reported real-world data on the device that showed a survival rate matching that of its pre-approval study when following the FDA’s approved protocol.

During the COVID-19 pandemic, Impella RP has been used for treating right heart failure or decompensation, including pulmonary embolism, according to a news release. It can be deployed in minutes using a minimally invasive technique.

The FDA granted EUA based on data from Impella RP’s approved indication and reported clinical experience. Under the authorization, healthcare providers may use the device in a hospital setting when providing temporary …