November 12, 2018
The Vascade MVP vascular closure system met its endpoints compared to manual compression in a pivotal clinical study for multi-access venous closure following electrophysiology (EP) procedures, according to manufacturer Cardiva Medical Inc. The AMBULATE study is the first randomized pivotal trial of vessel closure conducted exclusively by EP physicians.
November 07, 2018
The Lutonix Drug-Coated Balloon (DCB) showed statistically significant safety equivalence with a standard percutaneous transluminal angioplasty (PTA) catheter for the treatment of narrowed or obstructed arteries below the knee in recent trial results. The data were presented at the Vascular Interventional Advances (VIVA) 2018 annual conference, Nov. 5-8 in Las Vegas.
November 05, 2018
Cordis, a Cardinal Health company, today announced the U.S. launch of Mynx Control Vascular Closure Device (VCD). It integrates active extravascular sealing and bioresorbability properties with a next-generation delivery system to maximize predictability, safety, and ease of use in sealing 5-7 French femoral arterial access sites. Vascular closure devices reduce time to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
October 17, 2018
The U.S. Food and Drug Administration (FDA) has cleared an additional indication for rivaroxaban (Xarelto) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). The drug is now the first and only factor Xa inhibitor approved for patients living with these conditions. The drug is made by The Janssen Pharmaceutical Companies of Johnson and Johnson.
October 16, 2018
There is a hype cycle surrounding new technologies in all industries, but medicine is unique because of its focus on clinical trial data as one of the key determining factors of whether a new device becomes standard of care or dies on the vine. Here is a great summary of this cycle with cardiovascular devices.
October 12, 2018
Reva Medical presented four key data sets demonstrating the capabilities of the company’s Fantom bioresorbable scaffold (BRS) at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference.
October 08, 2018
While both blunt and bold, it resonated with me as it accurately summarized the cardiovascular information and imaging systems (CVIS) market, as well as my own experience with various CVIS deployments.
October 03, 2018
A high number of patients in a study who underwent transcatheter aortic valve replacement (TAVR) experienced severe and moderate cases of prosthesis-patient mismatch (PPM), meaning the implanted heart valve is too small for the patient, which can lead to inadequate blood flow.
October 01, 2018
Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluvia Drug-Eluting Vascular Stent System, specifically developed for the treatment of peripheral artery disease (PAD).
September 28, 2018
At one year following transcatheter aortic valve replacement (TAVR), implantation with the Portico valve was safe and associated with low rates of stroke, death and leaks between patients’ natural heart tissue and the Portico valve.