The first patient has been enrolled in Svelte Medical System‘s Optimize pivotal trial, which is designed to evaluate the safety and efficacy of Svelte’s drug-eluting stent integrated delivery system and rapid exchange platforms. The 2,000-person trial comes in the wake of a first-in-man trial for Svelte’s product and a study comparing the system with Medtronic‘s (NYSE:MDT) Resolute […]
Svelte Medical wins CE Mark for Direct coronary stent
Svelte Medical Systems said today that it received CE Mark approval in the European Union for its Direct sirolimus-eluting coronary stent. The stent uses a coating of sirolimus and a natural, amino acid-based polyesteramide bioresorbable drug carrier. Direct stenting minimizes the use of pre-dilation balloons, lessening the cost and time of stent procedures. Direct Rx is specifically […]
Svelte Medical launches Slender IDS in Europe
Svelte Medical Systems said today it initiated a select launch of its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system in Europe. The device incorporates Japan’s Asahi Intecc (TYO:7747) guide wire technology, specialized balloon design and a bioresorbable drug carrier from DSM Biomedical. The Slender’s all-in-one’ fixed-wire system with combined technologies allows for “precise steering” and controlled balloon […]
Svelte Medical granted CE Mark for Slender IDS drug-eluting stent catheter
Svelte Medical Systems said today it won CE Mark approval in the European Union for its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system designed to treat coronary artery disease. The Slender IDS is the lowest-profile drug-eluting stent on the market, according to the New Providence, N.J.-based company. Approval in the EU came based on data […]
MDT gets in on $17m Series B for Glooko | Medtech funding for the week of March 16, 2015
Svelte Medical adds $16m for wrist-delivered stent
Svelte Medical Systems today said it plans to use the $16 million it just raised to commercialize its wrist-delivered stenting technology.
New Providence, N.J.-based Svelte said the round involved current investors and was led by CNF Investments, the West Health Investment Fund and New Science Ventures.
Medtech funding for the week of Mar. 10, 2014
Svelte Medical raises another $5M
New Jersey-based Svelte Medical plans to accelerate regulatory efforts for its interventional cardiology products thanks to a new $5 million investment from West Health Investment Fund.
Svelte Medical Systems raises $22 million
Svelte Medical Systems said it raised $22 million to complete a clinical trial of its coronary stent platforms, taking its total raise to $65 million since 2007.
Venture capital shops New Science Ventures and CNF Investments led the latest round for New Providence, N.J.-based Svelte, which the medical device company said it plans to use to complete its Direct II clinical trial as it gears up for commercialization.
Svelte Medical launches drug-eluting stent trial
Svelte Medical said it launched the Direct II Phase II clinical trial of its drug-eluting stent comparing the device with Medtronic‘s (NYSE:MDT) Resolute DES.
The Svelte device elutes the anti-stenosis drug sirolimus using a bioabsorbable carrier made of amino acids, unlike the polymer-based drug carrier used in the Resolute stent.
Svelte treats 1st patient with Svelte Acrobat stent system
Svelte Medical Systems treated the 1st patient in its clinical study, evaluating the company’s Svelte Acrobat Integrated Delivery System in comparison with conventional coronary stent devices in treatment of patients with lesions eligible for direct stenting.
The Svelte coronary stent IDS is low profile and highly flexible, designed to streamline stenting and thereby reduce procedure time and cost, the company said.
