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November 21, 2013

Alvimedica Announces Merger With CID

November 19, 2013—Alvimedica Medical Technologies (Catalca, Turkey) announced a merger with CID: Carbostent & Implantable Devices SpA (Saluggia, Italy), which will be joined under the name Alvimedica. The merger provides Alvimedica with three research and development centers in Europe: Catalca, Turkey; Saluggia, Italy; and Assen, the Netherlands. Alvimedica's global marketing headquarters is in Amsterdam.

According to Alvimedica, the CID product portfolio is fully complementary to the cardiovascular product line currently marketed by Alvimedica and will allow it to grow in the cardiovascular and endovascular markets. In addition to strengthening its presence in the European market it already serves, Alvimedica's Chief Executive Officer Cem Bozkurt stated in the announcement that the company's next goal is entering the North American markets.

Alvimedica's portfolio of interventional cardiology devices, including drug-eluting stents (DES), bare metal stents, balloon catheters, catheters, and guidewires, can be found on its website. Alvimedica launched the Coracto rapamycin-eluting coronary stent in October 2011. Among its latest products is the Alviguide Blue+ cardiovascular guiding catheter. CID's portfolio of interventional products for the treatment of coronary and peripheral artery diseases is available on its website.

On November 5, 2012, CID announced European CE Mark approval for a 2.25-mm version of its coronary Cre8 polymer-free DES, which expands the device's size matrix with 2.25-mm to 4.5-mm diameters and 8-mm to 38-mm lengths. On July 25, the company announced that the coronary Cre8 device received additional CE Mark approval for a 31-mm length in small sizes and a 38-mm length for the entire product range. The first CE Mark approval of Cre8 was obtained in 2011.

CID announced European CE Mark approval for its Cre8 BTK peripheral DES for the treatment of below-the-knee lesions on July 18. The polymer-free DES is available with 2.5-mm to 4.5-mm diameters and 8-mm to 38-mm lengths, stated the company. In July 2011, CID launched Nimble, a 0.035-inch–compatible over-the-wire percutaneous transluminal angioplasty balloon. Also in July, CIT launched the Easy Flype and Easy HiFlype self-expandable peripheral drug-free stents for the treatment of the superficial femoral arteries and iliac arteries.

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November 22, 2013

FDA Guidance Document Addresses Design Considerations for Pivotal Clinical Studies

November 22, 2013

FDA Guidance Document Addresses Design Considerations for Pivotal Clinical Studies