Corvia Medical announced that it randomized the first patient in its Responder-HF global confirmatory trial of its atrial shunt. Tewksbury, Massachusetts-based Corvia designed its shunt for heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. Dr. Scott Lilly and Dr. Rami Kahwash enrolled and randomized the first patient at the Ohio State University […]
Corvia Medical
Corvia Medical closes $54M financing to support atrial shunt
Corvia Medical announced today that it closed a $54 million equity financing from its existing investor syndicate. Tewksbury, Massachusetts–based Corvia Medical earmarked the funds to support a confirmatory trial to build upon data and learnings from the clinical trial of its Corvia atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced HFmrEF […]
Corvia Medical reports encouraging results from trial of atrial shunt
Corvia Medical today announced positive data from the global phase III clinical trial of its atrial shunt in heart failure patients. Tewksbury, Massachusetts–based Corvia published analyses from its global, phase III Reduce LAP-HF II randomized trial of heart failure (HF) patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction online in Circulation. According to […]
Corvia Medical’s atrial shunt trial fails primary endpoint
Corvia Medical’s atrial shunt device did not reduce heart failure rates or improve health status in a 626-patient study published on The Lancet’s website. The REDUCE LAP-HF II results appear to be bad news for Tewksbury, Massachusetts-based Corvia — as well as Edwards Lifesciences, which agreed in 2019 to pay $35 million for the rights […]
FDA grants breakthrough nod for Corvia’s interatrial shunt
Corvia Medical said today that it won FDA breakthrough device designation for its interatrial shunt device for heart failure. The Tewksbury, Mass.-based company’s interatrial shunt is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s the world’s first transcatheter device indicated […]
Corvia Medical taps PhysIQ for remote monitoring in interatrial shunt study
Corvia Medical said it launched a heart failure device trial that will include the collection and analysis of data with PhysIQ’s continuous remote monitoring platform. The Phase III trial is designed to evaluate the efficacy of Tewksbury, Mass.-based Corvia’s interatrial shunt in patients with heart failure. The randomized, controlled, double-blinded study includes plans to provide […]
Corvia Medical’s interatrial shunt study meets endpoints
Corvia Medical said today that a clinical trial of its Interatrial Shunt Device for treating heart failure met its primary endpoints at one year. Tewksbury, Mass.-based Corvia last November launched the Reduce LAP-HF II clinical trial ahead of a bid for FDA approval. The company’s IASD is designed to lower blood pressure in the left atrium and […]
Corvia Medical launches Interatrial Shunt Device heart failure trial
Update: Corrected from previously mislabeled ‘interarterial’ to ‘interatrial’ shunts Corvia Medical said today it launched the Reduce LAP-HF II clinical trial of its transcatheter Interatrial Shunt Device designed to treat heart failure as it seeks FDA approval of the device. The Tewksbury, Mass.-based company said the 1st patient in the trial was enrolled by Dr. Rami Kahwash […]
Corvia Medical touts 1-year data for InterAtrial shunt
Corvia Medical today released 1-year results from the Reduce LAP-HF clinical trial of its InterAtrial shunt device, touting a good safety profile and sustained device performance. Results from the 64-patient study was presented at the American Heart Association’s 2016 Scientific Sessions. The Tewksbury, Mass.-based company’s IASD is designed to lower blood pressure in the left atrium […]
Corvia Medical lands CE Mark for heart shunt
Corvia Medical said today that it landed CE Mark approval in the European Union for its InterAtrial Shunt device for treating a type of heart failure. The IASD is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s indicated for diastolic heart […]
Corvia Medical wins FDA nod for trial, inks exclusive buyout deal with strategic backer
Corvia Medical said today that it won an investigational device exemption from the FDA for a clinical trial of its cardiac implant designed to treat diastolic heart failure and inked a deal with an unnamed strategic investor that includes an exclusive buyout option. Corvia’s transcatheter InterAtrial shunt device is designed to lower blood pressure in the left atrium […]
