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MedAlliance

Cordis acquires drug-eluting balloon maker MedAlliance for up to $1.135B

October 2, 2023 By Sean Whooley

MedAlliance SELUTION SLR

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 […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Featured, Mergers & Acquisitions, Vascular Tagged With: cordis, MedAlliance

MedAlliance picks up FDA IDE nod for drug-eluting balloon

January 10, 2023 By Sean Whooley

MedAlliance SELUTION SLR

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. […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: FDA, MedAlliance

MedAlliance enrolls first patient in study of drug-eluting balloon for treating erectile dysfunction

September 9, 2022 By Sean Whooley

MedAlliance SELUTION SLR

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. […]

Filed Under: Clinical Trials, Drug-Device Combinations Tagged With: MedAlliance

First U.S. patient enrolled in MedAlliance Selution SLR drug-eluting balloon trial

August 22, 2022 By Sean Whooley

MedAlliance SELUTION SLR

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Food & Drug Administration (FDA), Vascular Tagged With: MedAlliance

MedAlliance wins second FDA IDE nod for drug-coated balloon

August 9, 2022 By Sean Whooley

MedAlliance SELUTION SLR

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: FDA, MedAlliance

First patient enrolled in MedAlliance’s drug-eluting balloon trial

June 8, 2022 By Sean Whooley

MedAlliance SELUTION SLR

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 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Food & Drug Administration (FDA), Vascular Tagged With: MedAlliance

FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

May 26, 2022 By Sean Whooley

MedAlliance SELUTION SLR

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 […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Vascular Tagged With: MedAlliance

MedAlliance touts 18-month data for treating lesions with sirolimus-eluting balloon

October 8, 2021 By Sean Whooley

MedAlliance SELUTION SLR

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 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: MedAlliance

MedAlliance completes trial enrollment for sirolimus-eluting balloon for treating PAD

September 24, 2021 By Sean Whooley

MedAlliance SELUTION SLR

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 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: MedAlliance

MedAlliance enrolls first patient in drug-eluting balloon trial for erectile dysfunction

August 18, 2021 By Sean Whooley

MedAlliance SELUTION SLR

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, […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: MedAlliance

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