A Medical Device Daily

Berlin Heart (The Woodlands, Texas) reported that it has been awarded an Orphan Product Development Grant by the FDA, to support the ongoing Investigational Device Exemption (IDE) study of its Excor Pediatric Ventricular Assist Device (VAD).

Dr. Christopher Almond of the Children's Hospital of Boston, and Bob Kroslowitz, VP of clinical affairs for Berlin Heart, will serve as co-principal investigators for the grant project, "Safety and Efficacy of the Berlin Heart Excorr Pediatric VAD as a Bridge to Heart Transplantation."

The Berlin Heart Excor Pediatric VAD is a system for mechanical support of the heart in end-stage heart failure patients. It has been specifically designed for use in pediatric patients of all age groups ranging from newborns to teenagers. The device received unconditional approval for investigational use in pediatric patients in the US in October 2008 and is currently undergoing an IDE trial.

The goal of the Office of Orphan Products Development grant program is to encourage clinical development of products for use in rare diseases or conditions. At this time, only clinical studies qualify for consideration. All studies must be conducted under an Investigational New Drug application or an IDE. The grant awarded to Berlin Heart provides three years of support.

The number of grant awards varies each year depending on the availability of funds. On-going studies are funded first with the remainder of funds going to new studies. In recent years, the Office of Orphan Products Development Grant Program has funded nearly twelve to fifteen new awards annually.

In other grant news, The Cardinal Health Foundation (Dublin, Ohio) said it has awarded a total of $1 million in grant funding for new programs to improve patient safety at 35 hospitals, health systems and community health clinics across the country.

Grants of up to $35,000 per facility will provide funding for programs that implement creative and replicable methods to improve the quality of patient care. Examples of initiatives that received funding include: targeted screening for methicillin-resistant Staphylococcus aureus, strategies to improve physician hand hygiene, electronic medical record implementation and medication safety and reconciliation projects.