One of the biggest stories coming out of Transcatheter Cardiovascular Therapeutics’ annual meeting in Boston this weekend focuses on the success of Edwards Lifesciences Corp.’s freshly FDA-approved Pascal Precision transcatheter valve repair system in the CLASP IID trial, which compared it to Abbott Laboratories’ Mitraclip device in patients with degenerative mitral regurgitation (DMR) who were determined to be at prohibitive surgical risk.
Galvanize Therapeutics Inc. scooped up $100 million in a series B funding round aimed at advancing its pulsed electric field (PEF) energy platform. Completion of the financing coincided with the merger of Galvanize with two other med-tech startups built around the same core intellectual property portfolio: Gala Therapeutics Inc. and Galaxy Medical Inc.
The U.S. FDA has advised the public that it is in possession of 10 reports of squamous cell carcinoma and 12 reports of various lymphomas in connection with breast implants, a series of findings that are separate from known incidents of lymphoma.
The association of health care professionals in Normandy (APRIC) and the regional support group for the development of e-health in Normandy released new data on the importance of home telemonitoring in heart failure. Patients participating in the Suivi Clinique à Domicile (SCAD) heart failure home telemonitoring program experience less re-hospitalizations and lower death rates than patients with the same pathology but not on the program.
Angioplasty and stenting have combined to become the standard of care for patients with myocardia that sustained damage due to an infarct, but a new study suggests that some of these patients are no worse off with medical management compared to a trip to the cath lab.
Sichuan Jinjiang Electronic Science and Technology Co. Ltd. (JJET) recently completed series A+ and series B rounds, raising a total of ¥700 million (US$101 million) in series A and series B financing.
The use of leads for cardiac electrophysiology devices has proven nothing short of controversial in the past, usually an artifact of efforts to craft ever-skinnier leads that won’t disrupt the blood vessels into which they are placed. Dublin-based Medtronic plc is working to avoid these problems with leads without sacrificing the advantages of leads via its EV ICD system, which soundly passed the test in a study presented at this year’s edition of the European Society of Cardiology (ESC) annual scientific sessions.
Integra Lifesciences Holdings Corp., of Plainsboro, N.J., said in its latest 8K filing that it has decided to voluntarily remove all the company’s Cerelink systems – which are indicated for intracranial pressure monitoring – due to customer reports that these monitors were returning inaccurate pressure readings.
Investors in Cathvision ApS are backing the company with an additional $7.2 million to accelerate U.S. commercialization of its electrophysiology (EP) recording system, Ecgenius. The ECG support technology is designed to detect cardiac electrograms with minimal baseline noise so electrophysiologists can accurately interpret complex arrhythmias, including atrial fibrillation (AF). In May, the U.S. FDA granted the Copenhagen-based company 510(k) clearance for the system.
Scientists will investigate whether cutting-edge technology such as base editing could be used to cure inherited heart muscle conditions after an international team co-led by Harvard Medical School won a research challenge. The $36 million Big Beat Challenge, run by the British Heart Foundation, is one of the largest non-commercial awards ever given and will focus on inherited heart muscle diseases known as genetic cardiomyopathies.
