Cardiva Medical said today it won FDA premarket approval for its Vascade MVP venous vascular closure device. The Vascade MVP system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said. The device functions by placing a collapsible mesh disc against the inner vessel wall to stop […]
Cardiva Medical today released results from the pivotal study of its Vascade MVP vascular closure device intended for multi-access venous closure following electrophysiology procedures, touting that the trial met its primary and secondary endpoints. The results from the AMBULATE trial were presented today at the American Heart Association’s annual Scientific Sessions by Texas Cardiac Arrhythmia Institute […]
Cardiva Medical said today it won expanded indications from the FDA for its Vascade vascular closure system, now cleared for use in 5-7F femoral venous closures in addition to arterial closure. The Vascade system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said. The device functions by […]
Cardiva Medical said yesterday that it added another $11 million to a funding round it closed last year at $30 million to continue the commercialization of its Vascade vascular closure device. Existing debt and equity investors participated, including PTV Healthcare Capital, Canepa Healthcare and affiliates of Luther King Capital Mgmt., the Santa Clara, Calif.-based company said. […]
Vascular closure device dev Cardiva Medical said yesterday it closed a $30 million round of equity financing to support the commercial expansion of its Vascade vascular closure system. The round was joined by affiliates of Luther King Capital Management with participation from existing major investors, including PTV Healthcare Capital and Canepa Advanced Healthcare Fund, the […]
California medical device company Cardiva Medical won FDA approval for its Vascade extravascular closure device, the company announced this week.
The premarket approval was granted based on evidence from Cardiva’s 420-patient clinical trial, which demonstrated that Vascade beat the gold standard of manual compression for vascular closure patients undergoing percutaneous procedures via the femoral artery, according to a press release.
Quintiles is resuming its plans to raise more than $2 billion in bank financing.
The Durham, N.C.-based, contract research organization is planning to enter into a new $2.2 billion credit facility, with proceeds from the borrowed funding being used to refinance $1.7 billion in existing debt, including an offer to buy $525 million of 9.5 percent outstanding senior notes that are due in 2014.