Clinical Trials

Relievant’s Intracept intraosseous nerve ablation system is the only FDA-cleared neuromodulation device indicated to treat vertebrogenic pain. Boston Scientific will pay $850m for Relievant, plus undisclosed milestone payments over the next three years.

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

A small scale study has indicated that GLP-1 agonists could restore normal HbA1c levels in type I diabetics. This therapy could be a huge step forward for the treatment of this chronic disease if this benefit is shown in larger studies.

The company’s ColoAlert mRNA-based diagnostic has proven similarly efficacious to colonoscopy, while outperforming competing blood/stool-based diagnostics.

This week, Philips announced a legal settlement on recalled CPAPs and BiPAPs; the FDA released emergency preparation recommendations; ReCor prepared to bring Paradise RDN to the US market; and Abbott released the results of a trial comparing optical coherence tomography (OCT) to angiography for guidance during cardiac surgery.

Click Therapeutics and Indivior will develop a digital solution for treating substance use disorders, starting with opioid use disorders. Click already signed partnership deals with Otsuka and Verily and Boehringer Mannheim to co-develop digital therapeutics for patients with schizophrenia and major depressive disorder.

The European Commission is steering a new member state-driven project that aims to get to the bottom of factors causing delays to trials that simultaneously investigate a drug product with an IVD or a medical device, and propose some solutions.

This week, Medtronic presented data from two new real-world trials confirming that ICDs save lives; a restraining order was issued against EOFlow in Insulet’s intellectual property case; and Polarean’s MRI gas XENOVIEW received a new Medicare reimbursement code.  

A change in risk classification for some legacy spinal fusion devices under the new EU MDR means that certain products face stricter clinical evidence requirements, which expert group OSMA told Medtech Insight is “unnecessary” and “overly-burdensome” for manufacturers.

The majority of FDA’s circulatory systems devices panel agreed that ReCor’s Paradise ultrasound renal denervation system offers a safe and effective therapy for patients with hypertension. The panel’s endorsement means ReCor will likely be the first company to reach the US market with an RDN system.

FDA’s circulatory system advisory panel narrowly voted against Medtronic’s Symplicity Spyral, because one of the pivotal trials of the radiofrequency renal denervation system missed its primary endpoint and the patient population evaluated in the trial does not match the requested indication.

This week, FDA Commissioner Robert Califf described plans for restructuring the Office of Regulatory Affairs; Studies found chatbots don’t give trustworthy advice to cancer patients; and the owner of an Atlanta genetic testing lab was sentenced to 27 years in prison over a massive Medicare fraud scheme.  

Considering where and how a test will be used, and what kind of evidence regulators will want before clearing it, is key for developers of at home and point-of-care diagnostics.

Researchers, research offices and ethics committees are being encouraged to familiarize themselves with the new National Statement on Ethical Conduct in Human Research before it becomes applicable on 1 January 2024.

This week, the US FDA geared up for a renal denervation panel meeting; a microbiology panel meeting was announced; and a hyaluronic acid patch to promote rotator cuff healing, a novel spiral tampon, and a tibial neuromodulation device to treat incontinence all won FDA clearance.