Corvia Atrial Shunt Fails to Outperform Sham Procedure in Pivotal REDUCE LAP-HF II Trial, Files Prospectus Amid Mixed Clinical Evidence

Aug 11, 2024 22:15 CST Updated 22:15

Corvia

Medical Device Development and Manufacturing

Corvia MedicalPublication of Atrial Shunt Device in "JACC: Heart Failure"Corvia atrial shuntClinical Research Data ( REDUCE LAP-HF II), studies show that the experimental group (Corvia atrial shunt）There was no difference in efficacy between the two groups and the sham operation group.

REDUCE LAP-HF IIIt is a prospective, randomized, double-blind, sham-controlled study, with a total of 621 patients enrolled, including 309 in the treatment group and 312 in the sham procedure group. The primary endpoints of this study are cardiovascular death or non-fatal ischemic/embolic stroke, total heart failure events, and changes in health status.Hierarchical Composite Endpoint。

Specific Research Data

The primary endpoint at 2 years in the trial group (n=309) and the sham group (n=312) (win ratio: 1.01 [95% CI: 0.82-1.24]) or its individual components showed no difference.
The patency rate of the shunt in the trial group was 98% at 24 months.
There was no difference in cardiovascular mortality and nonfatal ischemic stroke between the two groups; however, major adverse cardiac events were more common in the trial group compared to the sham group (6.9% vs. 2.7%; P=0.018).
Compared with the sham control group, the patients in the trial group had an increase in right ventricular volume ≥30% (39% vs. 28%; P<0.001), but right ventricular dysfunction was uncommon, and there was no difference between the trial groups.
Among the respondents (n=313,Peak exercise pulmonary vascular resistance <1.74 WU and no cardiac rhythm management device), the experimental group was superior to the sham operation (win ratio: 1.36 [95% CI: 1.02-1.83]; P=0.037, heart failure events reduced by 51% [incidence rate ratio: 0.49 [95% CI: 0.25-0.95]; P=0.034]).
Among non-responders (n=265), the treatment group did not perform as well as the sham procedure (win ratio：0.73 [95% CI : 0.54-0.98]）。

HeartThe atrial shunt device is a miraculous product. Every large-scale clinical study has failed to meet the primary endpoint, whether it's Corvia Medical or V-Wave products (these two are currently recognized as benchmarks for atrial shunt devices). Moreover, the research data from both companies are filled with contradictory conclusions. Therefore, one can imagine.HeartThe future prospect of the atrial shunt device seems even more speculative than RDN back in the day.HeartThe road to gaining regulatory approval for the atrial shunt device is still long; technical simplicity does not equate to clinical value.

Corvia atrial shunt

Corvia atrial shuntIt is the first atrial shunt device to receive CE approval for marketing, and it is a transvenous and transseptal heart failure treatment product.Corvia atrial shuntIt is a coin-sized implant that is inserted during minimally invasive surgery, designed to create a channel between the left and right atria. By allowing the left atrium to decompress,Corvia atrial shuntCan address elevated pressures that cause heart failure symptoms。Corvia atrial shuntComposed of two parts: the implant and the delivery system;

The implant is a self-expanding metal cage-like device with a dual-disc design and a central opening. The implant is radiopaque and provides ultrasound feedback, allowing it to be visualized during the implantation process via imaging. Each side of the implant has nine legs, with the LA side featuring radiopaque markers at the end of each leg. The LA side of the implant is flat to allow the legs to lie flush with the LA wall, minimizing the LA profile when the implant is deployed. The right atrial side is curved to accommodate variable septal wall thickness, with only the leg tips contacting the right atrial wall. When fully expanded, the outer diameter of the implant is 19.4mm and the inner diameter is 8mm.

InterAtrial Shunt Device (IASD`) Demonstration`

Corvia atrial shunt

Corvia MedicalIt is a company dedicated to revolutionizing the treatment of heart failure by developing groundbreaking structural heart devices. Corvia atrial shuntIs the world's first company approved by the EU for the treatment of heart failure with a transcatheter device, used for treating HFpEF or HFmrEF. Currently Corvia atrial shuntHas already received FDA approval to conduct PMA-related clinical research in the United States.