Edwards Lifesciences wins FDA approval for PASCAL tricuspid repair
The indication covers severe symptomatic leakage despite medical therapy, with pivotal one-year findings due at TCT.
Adrian Kessler
A new United States tricuspid valve indication has widened the reach of PASCAL Precision as Edwards Lifesciences Corporation NYSEEW announced FDA approval on Wednesday. The company plans to present 1-year pivotal results at the TCT cardiology meeting, while its announcement gives no outcome figures.
The Oct. 21 release describes an indication to improve quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy. A multidisciplinary heart team must judge patients at intermediate or greater surgical risk and suitable for transcatheter edge-to-edge repair.
Edwards is a large structural heart device maker based in Irvine, Calif., supplying implanted valves and catheter-delivered treatments globally.
Edwards shares rose 0.84 per cent to US$89.00 on the NYSE at 9:41 a.m. EDT on Wednesday, according to NYSEEW. The release describes the tricuspid therapy as available in the United States but gives no separate launch date, hospital rollout schedule or sales forecast.
Pivotal Outcomes Remain To Be Presented
The CLASP II TR study compares PASCAL plus optimal medical therapy against optimal medical therapy alone. Its ClinicalTrials.gov record, updated Sept. 14, lists estimated enrollment of 1,270 across the randomized study, a single-arm registry and continued-access cohorts, rather than an approval analysis population.
The registered primary endpoint at six months combines death, right-ventricular assist device implantation or heart transplant, tricuspid intervention, heart-failure hospitalizations and improvement on a cardiomyopathy quality-of-life questionnaire. The trial is open-label, so patients and investigators know the assigned treatment.
Wednesday's announcement does not give the analyzed patient count, treatment-versus-control results, a p value or confidence interval. It also provides no pivotal adverse-event rates or account of FDA feedback on the study design.
The registered safety measures include major adverse events at 30 days, alongside longer follow-up for mortality and hospitalizations. Those planned assessments describe what investigators track; they do not establish the observed safety results supporting the new indication.
Edwards also disclosed FDA approval of PASCAL Ace with Capture Clarity for degenerative mitral repair. Its fluoroscopic indicators confirm when valve leaflets have been grasped, according to the company, addressing a procedural step distinct from the new tricuspid indication.
“This simplifies placement of the device and increases confidence in our ability to achieve a successful M-TEER outcome,” structural heart program director Santiago Garcia of The Christ Hospital Health Network said in the release.
Edwards says it now offers transcatheter repair and replacement therapies for both the mitral and tricuspid valves in the United States. That portfolio claim concerns the range of treatments available; the release supplies no comparison establishing which approach produces better outcomes for a particular patient.
Read more: Edwards Lifesciences gains FDA approval for expandable pediatric valve
TriClip Competes For Tricuspid Repair
Abbott Laboratories NYSEABT markets its TriClip system as a nonsurgical treatment to improve quality of life and functional status in patients with symptomatic severe tricuspid regurgitation. PASCAL's new indication places Edwards alongside that existing repair option, although Wednesday's release reports no head-to-head comparison with TriClip.
The iShares US Medical Devices ETF NYSEARCAIHI traded at US$54.25 at 9:42 a.m. EDT on Oct. 21, according to NYSEARCAIHI, providing a dated sector benchmark alongside Edwards' gain.
The next evidence milestone is TCT in San Diego, scheduled for Oct. 31 to Nov. 3. Edwards plans to present one-year CLASP IITR findings there, providing the next opportunity to assess the pivotal outcomes absent from its approval announcement.
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