Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe, the USA, and other markets. It also covers recalls, safety notices, and indication withdrawals. This report (Monday 28 October to Friday 1 November) features a CE mark approval for Vascade MVP (Cardiva Medical), FDA Breakthrough Device Designation for Surmodics’ Sundance SCB, and Japanese Shonin approval of the Valiant Navion system (Medtronic).
CE mark—Vascade MVP (Cardiva Medical)
Cardiva Medical has received the CE mark for its Vascade MVP venous vascular closure system. Additionally, the AMBULATE study has been published in JACC: Clinical Electrophysiology. According to a press release, the AMBULATE study demonstrates the safety and efficacy of the system compared with manual compression. The press release adds that in both the USA and Europe, Vascade MVP is the first and only vascular closure system designed and labelled specifically for multisite venous closure following electrophysiology procedures.
FDA approval—One Click MRI (HeartVista)
HeartVista has received 510(k) clearance from the FDA for its artificial intelligence (AI) assisted One Click MRI acquisition software for cardiac exams. A press release reports that with HeartVista’s solution, cardiac MRI is now simple, time-efficient, affordable, and highly consistent. It adds that, prior to the HeartVista system, the use of cardiac MRI has been largely limited due to a lack of trained technologists, high costs, longer scan time, and complexity of use.
FDA approval—PMA supplement for Optimizer Smart system (Impulse Dynamics)
Impulse Dynamics, developer of the Optimizer Smart system for delivering cardiac contractility modulation (CCM) therapy, has received FDA approval of a PMA supplement for its next generation, two-lead Optimizer Smart system for the treatment of heart failure.
FDA approval—XACT robotics system (XACT Robotics)
XACT Robotics has announced that its first robotic system was cleared to market in the USA for use during computed tomography (CT) guided percutaneous interventional procedures. A press release states that XACT’s technology is the “first hands-free robotic system combining image-based planning and navigation with insertion and steering of various instruments to a desired target across an array of clinical applications and indications”.
FDA Breakthrough Device Designation—Fully implantable LVAD (Medtronic)
Medtronic has received Breakthrough Device Designation from FDA for a novel implantable left ventricular assist device for patients with advanced heart failure. A press release reports that, rather than the current LVAD systems that require a driveline cable that extends outside the body to a controller, future system is designed to be fully implanted inside the body.
FDA Breakthrough Device Designation—Sundance SCB (Surmodics)
Surmodics has announced that the FDA has designated its Sundance sirolimus-coated balloon (SCB) catheter as a Breakthrough Device under the agency’s Breakthrough Devices programme. The FDA has already designed the sirolimus devices MagicTouch (Concept Medical), Virtue sirolimus-eluting balloon (Orchestra BioMed), and Selution sustained limus release (MedAlliance) as Breakthrough Devices.
FDA safety communication—AFX endovascular grafts (Endologix)
The FDA has issued a new safety communication about Type III endoleaks with AFX endovascular grafts (Endologix). According to the safety communication, there may be a higher risk of Type III endoleaks with the use of AFX with Duraply and with AFX2.
National Medical Products Administration (China)—Orsiro (Biotronik)
The Chinese National Medical Products Administration has granted market approval to Biotronik’s sirolimus-eluting Orsiro stent. A press release reports that the company expects to make the device, which has a biodegradable polymer, available to Chinese patients and physicians in the coming months. As the second largest drug-eluting stent market in the world, China is the next major country to approve Orsiro. In the last two years, the stent has become available in other important markets such as Japan and the USA.
Shonin (Japan)—Valiant Navion (Medtronic)
Medtronic has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Valiant Navion thoracic endovascular aortic repair (TEVAR) system. Consequently, the company has launched the system in Japan for minimally invasive repair of thoracic descending aortic aneurysms and complicated type B aortic dissections. According to a press release, the approval marks the third major geographical launch of the Valiant Navion following FDA and CE mark approvals of the system in late 2018.