We deliver a full spectrum of clinical research, market access, and regulatory consulting services from bench to commercialization in Colombia and the rest of Latin America.
In Battle Against Alzheimer’s, This May Be Ground Zero
Roche drug trial in Colombia focuses on extended family whose members are likely to carry a gene that can lead to dementia by age 45
Colombia promotes itself as a destination for clinical research
The goal is to position the country as the top destination in Latin America to conduct clinical research for the biopharma and medical device industry.
Colombia seeks to attract medtech companies for clinical trials
The government of Colombia, in collaboration with the clinical development firm Interventional Concepts, is actively seeking to promote Colombia as a destination for early-stage clinical trials. Between 1995 and 2013, 738 clinical trials were conducted in the country. Although approximately 90 percent of those studies were in the pharmaceutical space, a growing number are being performed in the medical technology field for companies such as Avinger, Kona Medical, and InterValve.
UHealth Physicians Test New Percutaneous Valve in Colombia
The Miller School’s International Medicine Institute and Angiografía de Occidente S.A., the institute’s affiliate in Cali, Colombia, are collaborating on assessing the feasibility and safety of Direct Flow, Inc.’s new transcatheter aortic valve implantation device.
Miami-based consultancy bringing more U.S. startups' phase I trials to Colombia
In an effort to attract entrepreneurs who will conduct clinical trials and expand their commercialization efforts in Latin America, Colombia has signed an alliance with Interventional Concepts to recruit US and European drug and medical device startups to conduct their trials at the over 120 GCP government-certified sites in Colombia.
Transcaval Retrograde Transcatheter Aortic Valve Replacement for Patients With No Other Access: First-in-Man Experience With CoreValve
The first transcatheter aortic valve replacement (TAVR) approach was antegrade transvenous transseptal. This approach obligated transseptal catheterization and a more circuitous path to deploy the valve. The procedural complexities associated with the transseptal approach led to its replacement by the “less complex” and most commonly utilized transfemoral (TF) arterial retrograde approach (1). However, approximately two-thirds of screened patients are not suited for the TF approach because of peripheral arterial disease (2). In addition, the TF approach is associated with a significantly higher rate of vascular complications when compared with other approaches (1,3). The available alternatives are transapical for the Edwards Sapien valve (Edwards Lifesciences, Irvine, California), subclavian/axillary for the self-expandable Medtronic CoreValve ReValving system (CV) (Medtronic, Minneapolis, Minnesota), and transaortic for both prostheses. Despite these options, more than 3% of patients with symptomatic severe aortic stenosis are believed to have anatomic or physiological features making none of these approaches feasible (2). We report our first-in-man experience and demonstrate the intraprocedural safety of the CV percutaneous aortic valve implantation using the novel retrograde caval-aortic approach in a subgroup of inoperable patients with severe aortic stenosis.