Abbott DES Trial: Abbott announces start of SPIRIT PRIME, the U.S. clinical trial of its next-generation Xience Prime everolimus-eluting coronary stent, during its July 15 second-quarter earnings call. The company expects to launch Xience Prime in the U.S. in 2012. Abbott recently began shipping Xience Prime to select accounts in Europe following receipt of a CE Mark in June (1"The Gray Sheet" June 29, 2009). Xience Prime is available in a broad range of sizes up to 38 mm. SPIRIT PRIME is a 500-patient, 75-center nonrandomized trial with two arms. The core size arm will follow 400 patients treated with a stent from 2.25 mm to 4.0 mm in diameter and 8 mm to 28 mm in length, and the long lesion arm will follow 100 patients with a stent 2.5 mm to 4.0 mm in diameter and either 33 mm or 38 mm in length. The primary endpoint is major adverse cardiac events
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.
