August 29, 2016 — SynCardia Systems, manufacturer of the Total Artificial Heart (TAH), announced that the judge overseeing its Chapter 11 reorganization has approved the conditions for the bankruptcy process.

The judge approved the following:

The American Medical Society for Sports Medicine (AMSSM) last week released a new position statement on cardiovascular pre-participation screening for athletes. The statement discusses current evidence and knowledge gaps while offering recommendations and future directions.

September 12, 2016 — Vivasure Medical announced last week that the company has completed a Series C financing of €16.2M ($18.3M). The funding will support European commercialization of the company’s PerQseal technology to meet the growing demand for absorbable, percutaneous vessel closure products, as well as execution of a U.S. Food and Drug Administration (FDA) regulatory study.

A Saint Louis University researcher has received a grant to study the effects of treating post-traumatic stress disorder (PTSD) on cardiovascular and metabolic health. Jeffrey Scherrer, Ph.D., associate professor in Family and Community Medicine, received $2,348,320 from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH).

Veniti Inc. has closed on $25 million in Series D equity financing from Boston Scientific Corp. The funds will allow Veniti to complete the VIRTUS Trial and regulatory filing for the Vici Venous Stent System. The trial is being performed under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE). The company also intends to expand product development and commercial operations.

September 9, 2016 — New research published Sept. 8 in the Open Access journal PLOS Biology reports the role of genes in congenital heart defects (CHD) is more complex than previously realized. The research conducted University of California Irvine biologists Anne Calof and Arthur Lander and colleagues also found that overall risk is determined by a combination of gene effects both inside and outside of the heart itself.

Carmat announced that the first implantation of its bioprosthetic artificial heart within the framework of the PIVOTAL study has been carried out. The implantation was conducted in accordance with the authorizations obtained from the ANSM (French national agency for the safety of medicines and health products) and CPP (patient protection committee).

Six-month preclinical data from trials of a Xeltis bioabsorbable aortic conduit were presented at the 2016 scientific meeting of the International Society for Applied Cardiovascular Biology (ISACB). The data was presented by Prof. Frederick Schoen, M.D., Ph.D., senior pathologist and executive vice chairman, Department of Pathology at Brigham and Women’s Hospital, and professor of pathology and health sciences and technology, Harvard Medical School.

September 8, 2016 — Prevencio Inc. announced that data on its new clinical and multi-protein panel to diagnose obstructive coronary artery disease was presented at the European Society of Cardiology (ESC) Congress. The data was presented by Principal Investigator James L. Januzzi, M.D., a practicing cardiologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School. 

Technological and administrative obstacles are significantly cutting into available time for physicians to engage with patients. Nearly half a physician’s office day is now filled by data entry into electronic medical records (EHRs) and administrative desk work, according to a new time-motion study conducted by experts at the American Medical Association (AMA) and Dartmouth-Hitchcock healthcare system. The study results were published in the Annals of Internal Medicine.

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