MedAlliance announced today that Cordis acquired it for a total consideration that could reach up to $1.135 billion. The companies initially announced the planned deal in October of last year. Cordis, which develops interventional cardiovascular and endovascular technologies, made a $35 million investment last year. Its upfront closing payment totals $200 million, with achievement milestones […]
MedAlliance
MedAlliance picks up FDA IDE nod for drug-eluting balloon
MedAlliance announced today that its novel sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE). Geneva, Switzerland-based MedAlliance can now initiate its pivotal clinical trial for the treatment of coronary de novo lesions. MedAlliance received its first IDE for Selution SLR in below-the-knee indications in May 2022. It picked up a second IDE in August. […]
MedAlliance enrolls first patient in study of drug-eluting balloon for treating erectile dysfunction
MedAlliance announced today that it enrolled the first patient in a trial for its drug-eluting ballon in treating erectile dysfunction. Geneva, Switzerland-based MedAlliance said an 82-year-old Taiwanese man enrolled in the initial trial. It will evaluate the Selution SLR sirolimus-eluting balloon for the treatment of erectile dysfunction (ED). The Perfect-Selution FIM study includes 54 patients. […]
First U.S. patient enrolled in MedAlliance Selution SLR drug-eluting balloon trial
MedAlliance announced today that the first U.S. patient was enrolled in a U.S. clinical trial of its novel sirolimus-eluting balloon. Geneva, Switzerland-based MedAlliance received FDA investigational device exemption (IDE) approval for its Selution SLR drug-eluting balloon in the below-the-knee procedures. One week later, the company enrolled the first patient in its multi-center FDA Selution4BTK trial in […]
MedAlliance wins second FDA IDE nod for drug-coated balloon
MedAlliance announced today that received conditional FDA investigational device exemption (IDE) for its Selution SLR system. The FDA IDE nod for the novel sirolimus-eluting balloon allows MedAlliance to initiate a pivotal clinical trial for use of Selution SLR in the treatment of occlusive disease of the superficial femoral artery (SFA). Geneva, Switzerland-based MedAlliance’s second IDE […]
First patient enrolled in MedAlliance’s drug-eluting balloon trial
MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon. Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK […]
FDA grants IDE for MedAlliance’s sirolimus-eluting balloon
MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon. Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent. Selution SLR features unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The […]
MedAlliance touts 18-month data for treating lesions with sirolimus-eluting balloon
MedAlliance today touted late-breaking clinical trial data demonstrating positive outcomes with its Selution SLR drug-eluting balloon. The company presented 18-month results from its Prestige below-the-knee (BTK) study evaluating the safety and performance of Selution SLR in treating long tibial occlusive lesions (TASC C & D) in patients with critical limb ischemia (CLI) at VIVA21. According to a […]
MedAlliance completes trial enrollment for sirolimus-eluting balloon for treating PAD
MedAlliance announced today that it completed patient enrollment for a trial of its Selution SLR sirolimus drug-eluting balloon. Geneva, Switzerland-based MedAlliance, along with Japanese partner MDK Medical, completed the enrollment following the acceptance of a Clinical Trial Notification (CTN) by the Pharmaceutical Products and Medical Devices Agency (PMDA) of Japan in June 2020. The study […]
MedAlliance enrolls first patient in drug-eluting balloon trial for erectile dysfunction
MedAlliance announced today that it enrolled the first patient in an erectile dysfunction (ED) feasibility study with its drug-eluting balloon (DEB). Nyon, Switzerland-based MedAlliance’s first patient was enrolled in the trial at the University of Rome Tor Vergata, Italy, under principal investigator Giuseppe Sangiorgi, a professor of cardiovascular interventional pathology. According to a news release, […]