Target Health Inc. congratulates SyntheMed Inc. for receiving FDA approval of Repel-CV, a device shown to reduce the severity of adhesions in children undergoing open-heart surgery (see Regulatory Affairs below). For this program in the newborn, Target Health provided regulatory, monitoring, data management, biostatistics and medical writing services. Target e*CRF® was used for electronic data capture (EDC) and Target Health prepared and submitted the PMA in electronic format (eCopy).

Target e*CRF® has now been used in 15 FDA approvals (NDA: 3, BLA: 1, PMA: 10, 510(k): 1). Approvals have also occurred in Europe and Canada. An NDA in Dermatology is pending at FDA, and an MAA is pending in the area of Women’s Health at EMEA. US NDAs in Women’s Health and an orphan Metabolic Disease will be submitted this year.

For more information about Target Health and any of our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors

TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

Adhesions are bands of scar tissue that develop after surgery, infection, or other trauma. The bands can develop in any part of the body but are most commonly found in the abdomen, pelvis, or chest. Cardiac adhesions bind the outer membrane of the heart to surrounding tissue, which may restrict heart activity and complicate any additional surgical treatment. While scar tissue is part of the body’s natural healing response, adhesions can become densely fibrous and difficult to surgically navigate, which can pose problems for patients who require repeat surgeries. In the US, there are 350,000 to 400,000 children with congenital cardiac abnormalities. Many neonatal and infant patients must undergo multiple surgeries before their defect is corrected, while other children require additional operations as they grow.

The FDA has announced the approval of Repel-CV that reduces the severity of adhesions in children undergoing open-heart surgery. Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions. Repel-CV provides physicians with another tool to help decrease this type of complication that may occur. Repel-CV is intended for children who are likely to require additional heart surgery. In a clinical study, patients who received Repel-CV were found to have less area of severe adhesions – 21% of the surgical site. Patients who did not receive Repel-CV were found to have severe adhesions occupying 47% of the surgical site. “Designing and testing medical devices for children is challenging because they are still growing,” said Daniel G. Schultz, director of FDA’s Center for Devices and Radiological Health. “Approval of Repel-CV is an example of FDA’s commitment to work with regulated industry to make more safe and effective pediatric medical devices available.” Repel-CV is manufactured by SyntheMed Inc. in Iselin, N.J.
For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

The earliest known use of medicinal plants had been around 1000 BCE, with visual and written evidence for the myrtle, the lily, the poppy and others. Now, scholars say, the dating of a volcanic eruption and botanically accurate wall paintings indicate that saffron has been a versatile medicine as long as 3,500 years ago. This assumption is based on frescoes at Thera, a Greek island in the Aegean, that have been thought to depict a goddess overseeing the production of perfume or spice. Instead, the authors say, the frescos, from 1500 or 1600 BCE show the goddess presiding over the manufacture and use of a drug from the saffron flower. ‘”We know the date of the frescos,” according to the authors, “‘because a volcanic eruption stopped the clock, much as was the case in Pompeii.” The paintings are in a building that archaeologists designate Xeste 3. In the building there is a divinity of healing associated with therapeutic saffron. The authors became convinced that the paintings depicted medicinal saffron, in part because they seem to focus on the crocuses that produce saffron. According to authors, “We see in the frescos the painted depiction of the line of saffron production from plucking blooms to the collection of stigmas. We see every stage in production except for the removal of the stigma. But what we have is enough to indicate that a manufacturing process took place.” The most striking evidence for the conclusion that the frescoes show a goddess of medicine, resides in written records from many countries about the use of saffron in 90 illnesses over four millennia. As for visual evidence, one fresco depicts a woman who appears to be treating her bleeding foot with saffron. Although up to now scholars had discounted the possibility of widespread saffron use because of its high cost, the authors point out that just a few milligrams are required for medicinal purposes. In fact, too much may prove fatal. Dr. Ellen N. Davis, a retired professor of archaeology at Queens College and specialist in the Bronze Age in the Mediterranean, said, “It’s the most valuable and convincing study of the medicinal uses of saffron in the ancient Mediterranean world.” Experts usually cite the first mention of saffron as appearing in an Assyrian botanical dictionary from the reign of Ashurbanipal in the seventh century BCE.

Researchers at Barts and The London School of Medicine have discovered that drinking just 500 ml of beetroot juice a day can significantly reduce blood pressure. The study could have major implications for the treatment of 1) ___ disease. Research reveals that it is the ingestion of dietary nitrate contained within beetroot juice and similarly in green, leafy vegetables – which results ultimately in decreased blood pressure. Previously the protective effects of vegetable-rich diets had been attributed to their 2) ___ vitamin content. The research team found that in healthy volunteers, blood pressure was reduced within just 1 hour of ingesting beetroot juice, with a peak drop occurring 3-4 hours after ingestion. Some degree of reduction continued to be observed until up to 24 hours after ingestion. Researchers showed that the decrease in blood pressure was due to the 3) ___ formation of nitrite from the dietary nitrate in the juice. The nitrate in the juice is converted in saliva, by 4) ___ on the tongue, into nitrite. This nitrite-containing saliva is swallowed, and in the acidic environment of the stomach is either converted into nitric oxide or re-enters the circulation as 5) ___. The peak time of reduction in blood pressure correlated with the appearance and peak levels of nitrite in the circulation, an effect that was absent in a second group of volunteers who refrained from swallowing their saliva during, and for 3 hours following, beetroot ingestion. More than 25% of the world’s adult population is hypertensive, and it has been estimated that this figure will increase to 29% by 2025. In addition, hypertension causes around 50% of coronary heart disease, and approximately 75% of strokes. In demonstrating that nitrate is likely to underlie the cardio-protective effect of a vegetable-rich diet, the research highlights the potential of a natural, low cost approach for the treatment of cardiovascular disease — a condition that kills over 110,000 people in England every year. The team stated that “Our research suggests that drinking beetroot juice, or consuming other nitrate-rich vegetables, might be a simple way to maintain a healthy cardiovascular system, and might also be an additional approach that one could take in the modern day battle against rising blood pressure”. The paper, “Acute blood pressure lowering, vasoprotective and anti-platelet properties of dietary nitrate via bioconversion to nitrite,” was published online in Hypertension.

ANSWERS

1) cardiovascular; 2) antioxidant; 3) chemical; 4) bacteria; 5) nitrite; 6) pressure