Abiomed Archives - Medical Design Sourcing

J&J’s Abiomed has a Class I Impella recall with 49 deaths related to issue

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]The FDA deemed a recall of heart pumps from Johnson & Johnson MedTech’s (NYSE:JNJ) Abiomed Class I, the most serious kind.

Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart.

This recall (a correction and not a product removal) affects a number of Impella pumps in the U.S. That includes Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAsist and Impella LD.

Impella pumps provide short-term support for the ventricles during high-risk catheter-based percutaneous coronary interventions (PCIs). Uses also include for ongoing cardiogenic shock, open-heart surgery or cardiomyopathy. The therapy aims to reduce the work of the heart’s ventricles and support the circulatory system.

Abiomed recalled the left-sided blood pumps in this…

FDA issues warning letter to J&J’s Abiomed for Impella heart pump problems

The Impella RP Flex with SmartAssist pump [Image from Abiomed]Abiomed, a Johnson & Johnson (NYSE: JNJ) + unit, has received an FDA warning letter related to its Class I recall of Impella heart pumps.

The agency wrote Abiomed up for failing to report problems with the heart pump and selling its Impella Connect System software and hardware without FDA authorization. The FDA issued the letter in September after inspecting Abiomed’s facility in Danvers, Massachusetts in March and April.

“We are working closely with the FDA to fully resolve the observations as quickly as possible,” Abiomed said in an emailed statement. “As we continue to integrate into Johnson & Johnson MedTech, we are implementing quality system process improvements related to the observations, and many of these corrective actions are already in process.”

“We are …

FDA deems latest Abiomed Impella recall Class I

The Impella RP Flex with SmartAssist. [Image from Abiomed]Abiomed, a Johnson & Johnson (NYSE: JNJ) + unit, issued another recall for some of its Impella heart pumps.

This marks the third safety notice regarding the heart pumps in as many months. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge sidearm of the pump. Last month, the company issued another Impella recall, this time for potential contact with transcatheter aortic valve replacement (TAVR) implants.

The FDA shared a notice labeling the recall as Class I, the most serious kind. It impacts 65 of Abiomed’s Impella RP Flex with SmartAssist devices in the U.S. It’s a voluntary correction — not a product removal.

Abiomed distributed affected devices between Nov. 1, 2022, and now, initiating the recall on June 29, 2023. …

J&J’s Abiomed recalls Impella again — this time it’s TAVR-related

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]Johnson & Johnson’s (NYSE: JNJ) + Abiomed unit issued another recall for some of its Impella heart pumps.

FDA communications dated July 14 confirmed the second recall in a month for certain Impella products. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge sidearm of the pump.

The latest medical device correction notice sent by Abiomed includes potential issues with six Impella models. It covers the Impella 2.5, Impella 5.0, Impella 5.5 with Smart Assist, Impella LD, Impella CP and Impella CP with Smart Assist. The issue relates to potential contact with transcatheter aortic valve replacement (TAVR) implants.

This marks the first communication regarding the issue in the U.S., a…

Abiomed recalls some Impella 5.5 with SmartAssist devices

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]The FDA today issued a field safety notice deeming a recall of Abiomed Impella 5.5 heart pumps as Class I, the most serious kind.

Abiomed — bought by Johnson & Johnson for $16.6 billion last year — recalled 466 affected devices. It distributed these Impella 5.5 with SmartAssist devices between Sept. 28, 2021, and March 6, 2023. The company initiated its recall on April 17. 2023.

This recall affects a subset of Impella 5.5 with Smart Assist systems. The latest versions with a preinstalled sidearm retainer and new yellow luer remain unaffected by this recall.

Impella 5.5 with SmartAssist supports the pumping chambers of the heart for up to 14 days when cardiogenic shock occurs less than 48 hours after a severe heart attack, open-heart surgery or when the heart functions poorly due to cardiomyopathy. Abiomed received customer complaints around the devic…

Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…

The top 10 cardiac device stories of 2022

[Image from Pixabay]From pulsed-field ablation to non-invasive monitoring, this was an exciting year for cardiac device tech.

Here are the top 10 cardiac device stories from MassDevice and its sister sites:

10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio

Earlier this year, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million.

9. Abbott confirms first implants of its dual-chamber leadless pacemaker system

The company designed its i2i technology to provide beat-by-beat communication between two leadless pacemakers, with one positioned on the right ventricle and the other in the right atrium.

8. Boston Scientific completes $1.75B Baylis Medical acquisition

The deal expanded Boston Scientific’s electrophysiology and structural heart product portfolios to include the radiofrequency (RF) NRG and VersaCross transseptal platforms. It also gained a family of guidewires, sheaths an…

Johnson & Johnson completes $16.6B Abiomed acquisition

Johnson & Johnson (NYSE:JNJ) announced today that it completed its $16.6 billion acquisition of Abiomed (Nasdaq:ABMD).

Abiomed now becomes part of Johnson & Johnson, operating as a standalone business within its MedTech segment.

“We are excited to officially welcome the talented Abiomed team to Johnson & Johnson. Their patient-first philosophy aligns with our credo and our purpose to change the future of health for humanity,” said Joaquin Duato, CEO of Johnson & Johnson. “This acquisition marks another important step on Johnson & Johnson’s path to accelerating growth in our MedTech business and delivering innovative medical technologies to more people around the world.”

Last month, Johnson & Johnson announced its intention to acquire Abiomed for approximately $16.6 billion. Under the agreement, Johnson & Johnson intends to acquire through tender offer all outstanding Abiomed shares.

Johnson & Johnson last week exten…

Abiomed wins FDA nod for Impella ECP pivotal heart pump trial

The Impella ECP. [Image courtesy of Abiomed]Abiomed (Nasdaq:ABMD) announced today that the FDA approved the version of Impella ECP for its upcoming pivotal trial.

Danvers, Massachusetts-based Abiomed enrolled the first two patients in its trial following approval. Dr. Amir Kaki, director of mechanical circulatory support at Ascension St. John Hospital in Detroit, led the procedures.

The single-arm, prospective, multi-center trial centers around Impella ECP support. Patients either receive the heart pump during elective or urgent high-risk percutaneous coronary intervention (PCI). It evaluates the rate of major adverse cardiovascular and cerebrovascular events (MACCE) in adult patients.

Impella ECP, the world’s smallest heart pump, has compatibility with small bore access and closure techniques. According to a news release, it comes in at 9 Fr in diameter upon insertion and removal from the body. Once in the body, it expands and supports the heart̵…

Johnson & Johnson extends tender offer for Abiomed acquisition

Johnson & Johnson (NYSE:JNJ) announced today that it extended the expiration date of its offer to acquire Abiomed (Nasdaq:ABMD).

Last month, Johnson & Johnson announced its intention to acquire Abiomed for approximately $16.6 billion. Under the agreement, Johnson & Johnson intends to acquire through tender offer all outstanding Abiomed shares.

The deal includes an upfront payment of $380 per share in cash. Abiomed shareholders also receive a non-tradeable contingent value right (CVR). This entitles the holder to receive up to $35 per share in cash upon the achievement of certain commercial and clinical milestones. Both companies boards of directors approved the transaction.

Upon announcing the transaction, Johnson & Johson said it intends to complete it before the end of the first quarter of 2023.

About the extension

Johnson & Johnson’s offer was previously scheduled to expire at 11:59 p.m. ET on Dec. 13, 2022, according …

FDA tightens indications for Abiomed Impella RP system

The Impella RP Flex with SmartAssist. [Image from Abiomed]The FDA announced today that it is updating the labeling on Abiomed‘s Impella RP Flex with SmartAssist to reflect the final post-approval study results.

Abiomed announced in October that FDA had approved the catheter-delivered heart pump system to provide temporary right ventricular support for up to 14 days. People can develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Now, the FDA has updated the labeling (changes in italics):

“The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery, withou…

Abiomed stock skyrockets on Q3 results ahead of Johnson & Johnson acquisition

Abiomed (Nasdaq:ABMD) shares soared before hours on third-quarter results and the news of its acquisition by Johnson & Johnson (NYSE:JNJ).

Johnson & Johnson announced this morning that it agreed to buy Abiomed for $16.6 billion.

Shares of ABMD skyrocketed up more than 50% at $378.30 apiece in morning trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 2%.

The Danvers, Massachusetts-based company posted profits of $106.1 million for the quarter. That totals $2.32 per share on sales of $265.9 million for the three months ended Sept. 30, 2022.

Abiomed reported an 86.4% bottom-line gain on year-over-year sales growth of 7.2%.

The company said it saw impacts on procedural volumes in July due to extended physician vacations. That, paired with ongoing hospital labor shortages, affected sales. Additionally, Abiomed observed improvements in patient utilization…