Medtronic trumpets 12-year heart valve study | Research roundup

After 12 years, Medtronic Inc.’s (NYSE:MDT) Mosaic bioprosthetic heart valves are still working, according to a study published online in The Journal of Thoracic and Cardiovascular Surgery.

The Minneapolis-based medical device giant touted the study that evaluated the performance of its Mosaic valve in patients who had aortic valve replacement (AVR) and mitral valve replacement (MVR).

The Mosaic valve is an artificial heart valve designed to replace a diseased or damaged heart valve, usually the aortic or mitral valve. The device was approved by the U.S. Food and Drug Administration in 2000.

"With 12 years of follow-up, the study revealed a freedom from structural valve deterioration of 93.3 percent of AVR patients 60 years and older and in 95.3 percent of MVR patients 70 years and older. In addition, hemodynamic performance data showed stability up to 10 years, indicating durability of the Mosaic bioprosthesis over time," the company said.

Here’s a roundup of recent clinical trial and scientific study news:

• Kuros treats first patient with its dural sealant product candidate
  Kuros Biosurgery AG treated the first patient in a pilot clinical trial investigating the safety and efficacy of KUR-023, its novel dural sealant product candidate. KUR-023 is a synthetic hydrogel-based sealant that utilises Kuros’ synthetic technology. The product candidate is administered as a spray with the aim of ensuring water-tight closure of incisions or tears through the dura mater. It is intended to be used as an adjunct to normal closure techniques such as suturing. The trial is a European, single arm, multi-center, study that will recruit 40 patients. The primary endpoint refers to the prevention of intraoperative leakage with secondary endpoints related to safety and further efficacy assessment. KUR-023 is delivered from a double barrelled syringe with a mixing spray tip. The product candidate is delivered as a spray which then arrives on the dura as a liquid, conforms to the surface, and quickly polymerises.
  Read more
• Caliper’s Phase I EPA ToxCast data makes the pages of Toxicology
  Caliper Life Sciences, Inc. (NSDQ:CALP) announced that the results of its initial screening efforts under the U.S. Environmental Protection Agency’s ToxCast program have been published in the scientific journal Toxicology. Key findings reported include a high level of quality and reproducibility in the dataset allowing for robust statistical analyses, and the role that specific targets in biological pathways could play in toxicity events. These findings underscore the success of the Phase I ToxCast effort and support continued expansion of the program to build predictive models for identifying chemicals with high risk for human toxicity or environmental hazard. Caliper has recently been awarded three new task orders with an aggregate value of $3.1 million to fund additional activities under the EPA ToxCast program.
  Read more
• OrbusNeich touts Genous stent study
  OrbusNeich announced that 12-month follow-up data from the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) registry published in the February issue of EuroIntervention demonstrated good clinical outcomes with low incidence of repeat revascularization and stent thrombosis (ST) for the company’s Genous Stent. Target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization (TVR), was 8.4 percent at 12 months. The composite of death, MI or target lesion revascularization (TLR) occurred in 7.9 percent of the patients. TLR and ST were 5.7 percent and 1.1 percent, respectively.
  Read more
• Biomoda completes patient enrollment for pilot study
  NewCardio Inc., (OTC:NWCI) announced that the Company has been invited by the Heart Rhythm Society (HRS) to present results of a recent clinical study showing that recurrent atrial fibrillation (AF) was accurately and timely detected in patients who used CardioBip for daily monitoring following catheter ablation procedures. The presentation, entitled "Long-term Intermittent Wireless Remote Monitoring of Reconstructed 12-Lead ECG in Post-Ablation AF Patients Using the CardioBip System", will be made at the 32nd Annual Scientific Sessions of the HRS, to be held in San Francisco, May 4-7.
  Read more
• Study: In IVF cycles, endometrium dramatically improves after G-CSF treatment
  During in vitro fertilization (IVF) cycles, treatment with a medication called granulocyte-colony stimulating factor (G-CSF) significantly improves inadequate endometrium (lining of the uterus), according to a report published electronically on February 15 in Fertility and Sterility – the official journal of the American Society for Reproductive Medicine (ASRM). The reported case series also suggests that G-CSF treatment may, in general, improve IVF pregnancy chances. G-CSF is a cytokine (protein molecules that facilitate communication between cells) that has already been FDA approved for other clinical indications. Researchers from New York City-based Center for Human Reproduction (CHR) and a second NY fertility center reported on four women with highly inadequate endometrium, unresponsive to conventional treatments and facing IVF cycle cancellation. In all four cases, endometrial perfusion of G-CSF expanded the endometrium to a minimal thickness of 7mm within approximately 48 hours, allowing for embryo transfer. Surprisingly, all four patients also conceived.
  Read more