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Heart Device Impresses FDA; Stryker Acquires Inari Medical

Alleviant Medical's new atrial shunt for heart failure treatment receives FDA breakthrough device designation. Stryker's acquisition of Inari Medical highlights the complementary nature of their vascular portfolios. Additionally, advancements in TAVR procedures and the EU availability of the Harmony TPVR system mark significant milestones in cardiovascular care.

The new atrial shunt developed by Alleviant Medical represents a significant advancement in the treatment of heart failure, offering a solution that does not require a permanent implant. This innovation has earned the FDA's breakthrough device designation, paving the way for further research and development.
In corporate news, Stryker, a leading medtech company, has announced the acquisition of Inari Medical, citing the complementary nature of Inari's peripheral vascular portfolio to Stryker's neurovascular offerings. This strategic move is expected to enhance Stryker's position in the vascular market.
On the procedural front, radial access continues to be the preferred method for many cardiologists performing PCI, due to its lower risk of complications. This preference is extending to secondary access during TAVR procedures, indicating a shift towards safer, less invasive techniques.
In regulatory developments, the Harmony TPVR system, approved by the FDA, is now accessible to patients across the EU. Nina Goodheart, president of Medtronic’s structural heart and aortic business, hailed this as a "significant milestone" in patient care.
Lastly, the FDA has issued a recall for over 200,000 pacemakers due to a battery issue that could potentially lock the device in safe mode, underscoring the importance of device reliability and patient safety in the medtech industry.
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[1]
Heart device impresses FDA | Stryker acquires Inari ...
cardiovascularbusiness.com · Jan 8, 2025

Alleviant Medical's atrial shunt for heart failure, FDA breakthrough designation. Stryker excited about Inari's vascular...

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