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Procedures

Trilogy Transcatheter Heart Valve

JenaValve Technology · FDA premarket approval

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The first transcatheter valve with a dedicated aortic regurgitation indication.

Clinical summary

Approved for symptomatic, severe aortic regurgitation in patients a Heart Team judges to be at high or greater risk for surgical valve replacement. Where earlier TAVR valves rely on annular calcium to anchor, Trilogy clips onto the native leaflets, so it can be implanted in non-calcified valves. Approval rests on ALIGN-AR, a single-arm study with no randomized surgical comparator.

Read the primary source: JenaValve press release

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Procedures

Infuse Bone Graft for TLIF

Medtronic · FDA approval (expanded indication)

rhBMP-2 bone graft is now approved for one- and two-level TLIF.

The approval extends Infuse (recombinant human bone morphogenetic protein-2) to transforaminal lumbar interbody fusion at one or two levels from L2 to S1, with PEEK or titanium cages, in patients with up to grade 2 spondylolisthesis. A randomized trial of 493 patients comparing two rhBMP-2 doses with local autograft stopped enrollment early after meeting its primary endpoints. Medtronic reports fusion rates above 90% for single-level TLIF.

OrthopedicsView Innovation
Drugs

Juvmo (tavapadon)

AbbVie · FDA approval

First selective D1/D5 dopamine agonist approved for Parkinson's disease.

A once-daily oral tablet for adults with Parkinson's disease, with or without levodopa; unlike existing agonists, which act mainly on D2/D3 receptors, it selectively activates D1/D5. In TEMPO-3, as adjunct to levodopa in patients with motor fluctuations, daily 'on' time without troublesome dyskinesia rose by 1.7 hours versus 0.6 hours with placebo. Warnings include orthostatic hypotension, hallucinations, dyskinesia and impulse-control urges.

NeurologyView Innovation
Medical Technology

Libre Duo

Abbott · FDA De Novo

First wearable sensor that tracks ketones and glucose together.

A 10-day sensor for people with diabetes aged 2 and older that measures ketones and glucose in interstitial fluid every minute and sends readings, trends and rising-level alerts to a smartphone. Across six clinical studies in more than 600 participants it tracked clinically meaningful ketone differences, including elevated ketones before the onset of diabetic ketoacidosis. Ketone readings should be interpreted with glucose values and symptoms, and do not replace confirmatory testing before treatment decisions.

EndocrinologyView Innovation