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Xeltis Set To Begin Human Trials Of Endogenous Tissue Pulmonary Valve

 
• By Reed Miller

A feasibility trial of Xeltis’ PV-001 bioabsorbable cardiac pulmonary valve, based on the company’s unique Endogenous Tissue Restoration technology, will begin this summer at four to six centers in Europe, Xeltis CEO Laurent Grandidier told Clinica.

A feasibility trial of Xeltis’ PV-001 bioabsorbable cardiac pulmonary valve, based on the company’s unique Endogenous Tissue Restoration technology, will begin this summer at four to six centers in Europe, Xeltis CEO Laurent Grandidier told Clinica.

This first-in-human trial will enroll about 12 patients, ages 2 to 22, who need surgical reconstruction of the right ventricular outflow tract to correct congenital malformations such as tetralogy of Fallot, truncus arteriosus, or pulmonary atresia. The primary endpoint of the trial is survival at six months after the implantation of the device

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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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LSX Europe: Women’s Health Education Is The Key For Unlocking VC Investment

 
• By Natasha Barrow

Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
• By Marion Webb

Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.

Abbott’s FreeStyle Libre CGM Reduces Cardiovascular Disease-Related Hospitalization

 
• By Natasha Barrow

The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.