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…

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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…

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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…

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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 …

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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…

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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…

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Johnson & Johnson to acquire Abiomed for $16.6B

Johnson & Johnson (NYSE:JNJ) announced today that it agreed to acquire Abiomed (Nasdaq:ABMD) for approximately $16.6 billion.

Under the agreement, Johnson & Johnson intends to acquire through tender offer all outstanding Abiomed shares. That amounts to an upfront payment of $380 per share in cash. Johnson & Johson plans to complete the transaction before the end of the first quarter of 2023.

Shares of ABMD skyrocketed up more than 50% at $378.30 apiece in morning trading today. The company also reported its third-quarter earnings this morning. Meanwhile, JNJ shares dipped slightly at $172.82 apiece. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 2%.

Abiomed shareholders will 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. B…

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FDA approves Abiomed Impella RP Flex with SmartAssist for treating right heart failure

The Impella RP Flex with SmartAssist. [Image from Abiomed]Abiomed (Nasdaq:ABMD) announced today that the FDA granted its Impella RP Flex with SmartAssist pre-market approval (PMA).

Danvers, Massachusetts-based Abiomed designed the Impella RP Flex with SmartAssist to treat right heart failure. It does so for up to 14 days. The company intends to introduce Impella RP Flex in the U.S. through a controlled launch this quarter.

The FDA indicated Impella RP Flex with SmartAssist for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2. These patients develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Patients receive the Impella RP Flex via implant into the internal jugular (IJ) vein. This enables patient mobility, according to a news release. The heart pump also features dual-sensor techno…

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5 top trends shaping the medtech industry

Ashley McEvoy (left), Michael Minogue (middle) and Barry Rosenberg (right) speak at AdvaMed’s The MedTech Conference in Boston.

Ashley McEvoy is an industry veteran and the EVP and worldwide chair of Johnson & Johnson MedTech. Michael Minogue, another veteran, serves as chair, president and CEO of heart pump maker Abiomed.

Together, the two bring a wealth of medtech industry knowledge to the table. They demonstrated that in a “CEOs Unplugged” discussion at AdvaMed’s The MedTech Conference today.

McEvoy and Minogue joined Boston Consulting Group Managing Director and Senior Partner Barry Rosenberg onstage to discuss major medtech trends. The two went in-depth on five that they see in the industry right now: AI, health equity, hospital care, talent and climate change.

Here is more about the five trends:

1. AI

McEvoy said there is discussion over the potential framework for how to embrace artificial intelligence (AI) and m…

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Abiomed reaches new regulatory milestone for its Impella pumps

This screen shot from an Abiomed video demonstrates placement of the Impella 2.5 and Impella CP. Delivered in a minimally invasive way, Impella pumps actively unload the heart, aiding native heart recovery. [Image courtesy of Abiomed]Abiomed (Nasdaq:ABMD) announced that the FDA accepted and closed its post-approval study reports for its Impella heart pumps.

Danvers, Massachusetts-based Abiomed’s study reports relate to Impella’s premarket approvals (PMA). The company said in a news release that the FDA’s action represents “another affirmation” of the safety and effectiveness of Impella heart pumps.

Impella pumps treat cardiogenic shock, high-risk PCI and post-cardiotomy cardiogenic shock. They also cover cardiogenic shock in the setting of myocarditis or cardiomyopathy and right heart failure.

Abiomed said the FDA typically requires post-approval studies for medical devices under PMA. Post-approval studies use high-quality, pro…

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FDA clears Impella low-profile sheath from Abiomed

The Impella low-profile sheath. [Image from Abiomed]Abiomed (Nasdaq:ABMD) announced today that it received FDA 510(k) clearance for its Impella low-profile sheath.

Danvers, Massachusetts-based Abiomed designed its sheath to maintain the same inner diameter as the existing 14 French (Fr) sheath used for Impella CP placement. However, the new sheath reduces the outer diameter by nearly 2 Fr.

The sheath’s smaller size, along with other technological advancements, facilitates easier Impella insertion and removal. Abiomed said in a news release that it helps to reduce procedural steps and help improve outcomes.

Get the full story at our sister site, Medical Tubing & Extrusion.

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Abiomed Impella heart pump performs well in Japan study

Abiomed (Nasdaq:ABMD) announced today that a three-year study in Japan demonstrated positive results for its Impella heart pump.

Danvers, Massachusetts-based Abiomed’s study is an update to 2020 interim analysis. Results were presented at TCT 2022 in Boston.

The investigator-led study evaluated all Impella-supported patients across 109 hospitals in Japan. Of the 1,344 AMI cardiogenic shock (AMICS) patients, 30-day survival rates totaled 81%.

The analysis examined 293 consecutive Impella-supported AMICS patients in the J-PVAD Registry. Results also showed 81% survival at 30 days. Historical cardiogenic shock survival rates without Impella are approximately 50%, Abiomed said in a news release.

“The results of this study demonstrate that when Impella is used and best practices are followed, it is possible to achieve heart recovery and greater than 80% survival rates for patients with AMI cardiogenic shock,” said lead investigator Dr. Junya Ako,…

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