Encouraging data presented on the Corvia IASD, FirstClinTech proud to participate
22 November 2016
At the recent late-breaking sessions at the American Heart Association Scientific Sessions 2016, Professor David Kaye of The Alfred Hospital in Melbourne, Australia, presented one-year follow-up data from the REDUCE LAP-HF clinical study of Corvia Medical’s InterAtrial Shunt Device (IASD®). The IASD is the world’s first transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF), previously called diastolic heart failure. FirstClinTech was very involved in the conduct of the REDUCE LAP-HF Study in Europe, driving both patient recruitment and actively supporting implant procedures and invasive follow up procedures.
The results of the ongoing 64-patient study confirm a good safety profile, sustained device performance (blood flow from the left to right atrium) and clinically meaningful patient-focused outcomes including fewer heart failure symptoms, the ability to exercise longer, and a substantially improved quality of life. Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical, was quoted as saying “We are encouraged that the longer-term follow-up continues to demonstrate statistically significant, and even more importantly, clinically-meaningful results as we aim to improve the lives of patients around the world who suffer from heart failure”. Dr. Komtebedde worked closely with FirstClinTech to ensure that this study, unique in the field of HFpEF, succeeded in meeting its enrolment goals on time.
Dr. Komtebedde recognized the contributions made by FirstClinTech: “FirstClinTech provided very experienced and professional support to help us execute this challenging study in a timely manner. Working closely together we were able to meet the needs of the sites, ensure that study goals were met and high quality data was generated. The close collaboration between Corvia Medical, FirstClinTech, our CRO MedPass International, and of course the Investigators and their teams has proven to be a winner in a complex therapeutic field”.
Terry McCarthy, Managing Director of FirstClinTech, said “We are delighted to have contributed to the success of this study, and are looking forward to working together with Jan Komtebedde and his colleagues to further investigate this exciting therapy in larger, randomized studies”.
Note: IASD is a registered trade mark of Corvia Medical Inc. The IASD is not available for commercial distribution in the United States. The IASD device is CE-Mark approved in the European Union (see previous news item)