V-Wave concludes subject enrolment in Ventura Interatrial Shunt trial

V-Wave has concluded subject enrolment in the RELIEVE-HF pivotal clinical trial of the V-Wave Ventura Interatrial Shunt for heart failure (HF).

The sham-controlled, multi-centre, prospective, double-blinded, randomised trial has been designed to evaluate the V-Wave Ventura Interatrial Shunt’s effectiveness and safety in treating HF to reduce future hospitalisations and improve the quality of life for HF patients.

In the study, 508 advanced HF patients were enrolled in 101 hospitals from 11 countries. Patients with reduced and preserved left ventricular function etiologies for HF were also included.

The participants were randomised in a 1:1 ratio to either the Ventura Shunt treatment arm or a sham control arm.

Missing data: risk of assessment bias joins the long tail of Covid-19 impact on clinical trials

It has been well reported that the Covid-19 pandemic had a direct impact on the execution of clinical trials, such as patients being unable to visit clinical sites or procedures being affected by staff shortages. Now, questions have arisen about the best way to analyse missing data due to disrupted assessments and retain statistical power without introducing bias.

Clinical trials that were using time-to-event endpoints are particularly prone to misalignment between the scientific question that the trial intends to answer and the statistical analysis. For example, progression-free survival (PFS), one of the most frequently used endpoints in oncology trials, is a major concern, state authors of a recently published research paper.

FDA moves to make effect on health equity part of breakthrough device considerations

The Food and Drug Administration has proposed changes to its breakthrough device program to clarify the language about technologies that benefit populations suffering from health disparities.

Through the draft document, the agency is seeking feedback on changes to two sections of the breakthrough guidance it finalized in 2018.

The sections address designation considerations and the designation review process.

If it finalizes the proposal, the FDA will expand its breakthrough program to devices that improve accessibility because they may be more effective in patients with limited or no available options.

Nines

US-based company Nines is a tele-radiology and artificial intelligence startup. Its product NinesAI is FDA-cleared to triage time-critical, life-threatening indications of mass effect and intracranial hemorrhage.

Lucira Health

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Bloomlife

US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.