St Jude Medical has released positive clinical results for the 23mm and 25mm Portico transcatheter aortic heart valves in the Portico Transfemoral CE Mark study (Portico TF CE trial).
The non-randomised, multi-centre Portico TF CE trial was conducted to evaluate the Portico 23mm transcatheter heart valve, which received CE Mark in November 2012, and was later expanded to include the 25mm Portico valve.
According to the company, the clinical data for the 25mm Portico valve are currently under regulatory review to support CE Mark approval.
The enrolled patients in the study have demonstrated a significant improvement in valve function at one-month.
The initial findings indicate an impressive haemodynamic performance (the ability to maximise blood flow) and improvement in the severity of heart failure symptoms as measured by the New York Heart Association (NYHA) Functional Classification System.
These patients are candidates for a transcatheter aortic valve replacement (TAVR) procedure, as many are considered high-risk for conventional open-heart valve replacement surgery.
Lead investigator Dr Ganesh Manoharan of Royal Victoria Hospital in Belfast, UK, presented one-month results from the Portico CE study of 84 patients, reporting a 3.6% mortality rate, 2.4% major stroke rate, 10.8% pacemaker implantation rate and 10.8% major bleeding rate.
Additional study results reinforce safety and efficacy of the Portico valves beyond 30 days in the subset of patients that have completed longer-term follow up.
"The Portico valve’s self-expanding stent design and ability to be repositioned prior to deployment helps ensure precise valve placement, potentially improving patient outcomes and reducing the likelihood of complications such as a post-procedural pacemaker," Dr Manoharan said.
The Portico valve is implanted using a catheter placed through a small incision in the femoral artery to restore normal blood flow to the heart and treat severe aortic stenosis.
It is the only approved transcatheter valve that can be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site, or retrieved before being released from the delivery system.
St Jude Medical Cardiovascular and Ablation Technologies Division president Frank J Callaghan said the company has a long history of developing world class heart valve technologies.
"Today’s positive results speak to our capability and commitment to bring meaningful advancements to patients with heart valve disease," Callaghan said.
The data was presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
The Portico transcatheter aortic heart valve and transfemoral delivery system are not currently approved for use in the US.
According to GlobalData estimates, the transcatheter heart valves market in the US was valued at $280m in 2012 and is expected to grow at a CAGR of 25.3% to reach $1.36bn by 2019.
Image: The 23mm Portico Transcatheter aortic heart valve restores normal blood flow to the heart for treating severe aortic stenosis. Photo: courtesy of St Jude Medical, Inc.
