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New Access Devices Create Gateway To Interventional Structural Heart Disease

Now that transcatheter heart valves have been implanted in thousands of humans, it’s becoming clear where the problems lie. Vascular and bleeding complications, stroke and paravalvular leaks are the most troubling consequences. Most of the focus has been on improving the valves and the delivery systems, but now innovators are looking at the issue of access – the particular ways by which therapeutic devices enter the heart – and how it can be changed to improve outcomes. In this issue we profile Apica Cardiovascular, Entourage Medical and Inseal Medical.

With any new medical treatment, there are two types of risks: those that are known and anticipated from pre-commercial clinical work, and those that are unknown, can’t be predicted and only emerge once a device or procedure is exposed to real-world clinical practice. New products and procedures start out by being vetted in the protected, false security of clinical trials, involving small numbers of hand-picked patients often treated by leading physicians under ideal circumstances. Only as real-world clinical experience accumulates in large numbers of patients with a multitude of unpredictable co-morbidities and complications do the unanticipated problems begin to emerge.

That’s where TAVI (transcatheter aortic valve implantation) is today. Minimally invasive transcatheter treatments for the aortic valve as an alternative to surgical valve replacement have been available in Europe since...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

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TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.