Movair, a respiratory therapy company formerly known as International Biophysics Corporation, announced the U.S. commercial launch of Luisa, an advanced ventilator intended for use in homes, institutions, hospitals or portable applications for both invasive and non-invasive ventilation. Luisa can be used through the FDA’s Emergency Use Authorization* in response to the increasing need for safe and effective ventilators. Luisa is a portable and compact home ventilator now available in the U.S. and one of the first with the added benefit of high-flow oxygen therapy.

For patients with chronic and acute respiratory conditions that require long-term ventilation, prolonged compliance is critical. Luisa was designed to help patients embrace everyday experiences and active, mobile lifestyles. Weighing only eight pounds, Luisa includes a battery run time of up to 18 hours and offers patients eight adjustable comfort settings to deliver personalized, tailored therapy.

Luisa also features a rotatable 10-inch display and flexible connectivity options so patients can integrate the ventilator into current lifestyle habits such as sleeping on a certain side of the bed. Additionally, Luisa can be programmed in multiple languages, ensuring a multitude of diverse patients, families and caregivers receive understandable alarm notifications.

“Life supporting ventilation with high-flow therapy using the Luisa device proved to be a true asset during the most recent COVID-19 surge,” said Rami Arfoosh, MD, FCCP, Pulmonary and Critical Care Specialist and Associate Professor of Medicine at Medical College of Georgia, AU/UGA Medical Partnership. “It provided a new option to meet the high-flow needs for some patients in their home environment. Those patients would have otherwise continued to occupy hospital beds because of the lack of equipment that meets their needs at home. Luisa also provides the unique feature of switching back and forth between high-flow nasal cannula (HFNC) and non-invasive ventilator (NIV) with different mode by the push of a button.”

Luisa provides respiratory support and utilizes all standard volume, pressure and mouthpiece ventilation modes with the added benefit of high-flow oxygen therapy that can support nocturnally ventilated patients during the day with a less intrusive nasal cannula. High-flow oxygen therapy delivers a blend of air and oxygen that meets or exceeds a patient’s inspiratory flow demand to improve oxygenation and decrease the workload of breathing.

“Increased respiratory patient illness, COVID-19 and product recalls have created a critical need for ventilators in the United States,” said David Shockley, CEO of Movair. “We’re addressing this demand with the launch of Luisa, a portable and compact home ventilator, designed and made in Germany, that also provides patients with high-flow oxygen therapy. At Movair, we’re committed to advancing life-empowering respiratory therapies that help patients breathe better and live better. The launch of Luisa underscores this commitment.”

Luisa is the third-generation ventilator developed and manufactured by Lowenstein Medical in Germany, and marketed in Europe since 2020. It can be prescribed to patients diagnosed with chronic respiratory failure due to chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) dependent on meeting certain qualifications. Luisa can provide high-flow therapy to patients that need at-home ventilation and also offers FIO? and SPO? monitoring and ventilation from 100 ml VT.

Movair is the exclusive U.S. dealer for Lowenstein Medical. While Luisa can be purchased through various durable medical equipment (DME) providers, normally it is provided to patients by these DMEs through private or government health insurance. In August, Movair began pre-marketing Luisa, which is already being used by thousands of patients in the U.S. Many of these patients are recovering post-COVID and were transitioned home with Luisa.

In addition to launching Luisa, the company also announced a new name and rebrand to coincide with the company’s renewed focus on strengthening and streamlining its position as an industry-leading provider of innovative respiratory therapy technologies. For nearly 30 years, Austin-based Movair, formerly known as International Biophysics Corporation, has advanced and manufactured life support equipment including heart pumps, surgical instruments, medical molding and home medical equipment. The company is best known for the development of AffloVest, the first fully mobile and battery-operated respiratory airway clearance vest in the United States.

Movair is committed to advancing new respiratory solutions that provide patients with more opportunities to embrace the everyday experiences made much more difficult by their conditions. The company is poised to accelerate the growth of its respiratory therapy portfolio throughout the next 12 months.

Medtronic plc, the global leader in medical technology, announced it has received CE Mark for the Hugo™ robotic-assisted surgery (RAS) system, authorizing the sale of the system in Europe. CE Mark approval is for urologic and gynecologic procedures, which make up about half of all robotic procedures performed today.

“This day has been a long time coming, not just for Medtronic, but for the surgeons and hospital leaders who have partnered with us on this journey to bring the benefits of robotic-assisted surgery to more patients around the world. We know our solution is more meaningful because of their insights,” said Megan Rosengarten, president of the Surgical Robotics business, which is part of the Medical Surgical Portfolio at Medtronic. With the Hugo RAS system in our European customers’ hands and our dedicated team by their side, together we will redefine what is possible in robotic-assisted surgery.

The Hugo RAS system was designed to address the historic cost and utilization barriers that have stifled robotic surgery adoption for two decades. Globally, about 3% of surgeries are performed robotically,1 despite offering patients the benefits of minimally invasive surgery — fewer complications, shorter hospital stays, and faster return to normal activities.2–4,† In Western Europe, about 2% of procedures are done robotically while the majority, approximately 65%, are open surgery.1 The remainder are traditional minimally invasive surgery.1

Robotics and artificial intelligence are the undeniable future of healthcare, with incredible potential to not only advance patient care, but increase access to these benefits,” said Rob ten Hoedt, executive vice president and president of the Europe, Middle East, and Africa (EMEA) region at Medtronic. “The Hugo RAS system builds on our leadership in minimally invasive surgery, and we’re thrilled to provide hospitals across Europe a robotic-assisted surgery system that is thoughtfully designed to meet their needs today and tomorrow. We’ve had strong interest from leading surgical centers across Europe and expect to move quickly with multiple installations in several countries.”

These hospitals will be the first in Europe to join Medtronic’s Partners in Possibility Program, a group of pioneering institutions that will be among the first in the world to use the Hugo RAS system and participate in the global patient registry. Clinicians from these hospitals will participate in hands-on training at Medtronic Surgical Robotics Experience Centers, including two flagship sites operated in partnership with the ORSI Academy in Ghent, Belgium, and IRCAD in Strasbourg, France.

CE Mark approval comes on the heels of major milestones in the Hugo RAS system global launch, including the first urological and gynecological procedures, which took place in Latin America and India and marked the start of the Hugo RAS system global patient registry. A modular, multi-quadrant platform designed for a broad range of surgical procedures, the Hugo RAS system combines wristed instruments, 3D visualization, and a cloud-based surgical video capture option in Touch Surgery™ Enterprise with dedicated support teams specializing in robotics program optimization, service, and training.

The Hugo RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the EU, the Hugo RAS system is CE marked. In the U.S., the Hugo RAS system is an investigational device not for sale. Touch Surgery Enterprise is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition.

About Medtronic
Medtronic plc,headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies — alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Boston Scientific Corporation announced positive data for the Eluvia™ Drug-Eluting Vascular Stent System (Eluvia stent) during a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas. Data presented included one-year results from the EMINENT trial, which demonstrated superiority of the Eluvia stent compared to self-expanding bare metal stents (BMS) for the treatment of patients with peripheral artery disease (PAD) and superficial femoral artery (SFA) or popliteal artery (PPA) lesions up to 210 mm in length. The study enrolled 775 patients, making it the largest randomized trial of a drug-eluting stent for the treatment of PAD to date.

In the trial, the Eluvia stent exhibited superiority with a primary patency rate of 85.4% versus 76.3% with BMS (p=0.0087).1 The analysis also confirmed a significantly greater rate of sustained clinical improvement without reintervention, 83.0% for patients treated with the Eluvia stent compared to 76.6% for those treated with BMS (p=0.0450). Further, there was no significant difference in major adverse events or all-cause mortality rates between patients treated with the Eluvia stent and those treated with BMS through one year.

“I am honored to have been part of this global study, which adds to the robust body of evidence from the IMPERIAL trial and confirms that the Eluvia stent should be considered the stent of choice for treating SFA and PPA lesions of intermediate length,” said Professor Yann Gouëffic, M.D., Department of Vascular and Endovascular Surgery at Paris Saint-Joseph Hospital, France and principal investigator of the EMINENT study.2 “The superior primary patency rates and greater rates of clinical improvement without reintervention are reassuring for physicians looking to make clinically-based treatment decisions for their patients and reduce the need for repeat procedures.”

The Eluvia stent was developed for the treatment of PAD – the narrowing of the arteries of the legs due to plaque buildup – which affects approximately 8.5 million people in the United States and more than 200 million people worldwide.3,4 Left untreated, PAD restricts blood flow to the legs and feet and patients often experience pain, swelling and a diminished quality of life. The Eluvia stent, which features sustained release of the lowest dose of paclitaxel of any peripheral drug-eluting device, re-opens blocked arteries and restores blood flow while utilizing a drug-polymer combination to prevent tissue regrowth.

“We are committed to meaningful clinical trials designed to evolve clinical practice, and on the heels of the positive RANGER II SFA data presented yesterday, we are pleased that the EMINENT trial establishes the Eluvia stent as the first drug-eluting stent to demonstrate superior primary patency rates compared to bare metal stents in a head-to-head randomized trial,” said Michael R. Jaff, D.O., chief medical officer and vice president clinical affairs, technology and innovation, Peripheral Interventions, Boston Scientific. “The breadth of our portfolio, as the only company offering both a drug-coated balloon and a drug-eluting stent for the treatment of patients with PAD, provides physicians with evidence-based and highly-differentiated treatment options.”

For more information on the Eluvia stent, visit www.bostonscientific.com/eluviaclinicaltrials.

About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit and connect on Twitter and Facebook.

BD (Becton, Dickinson and Company), a leading global medical technology company, announced it has strengthened the U.S. government’s access to safety injection devices through increased manufacturing capacity and domestic supply. The new syringe and needle manufacturing lines, which were completed on an accelerated timeline, represent the public-private partnership between BD and Department of Health and Human Services’ (HHS) Assistant Secretary for Preparedness and Response (ASPR).

In July 2020, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) invested approximately $42 million into a $70 million capital project to further expand BD’s operations and manufacturing lines in Holdrege, Neb. The expansion builds on the company’s deep commitment and legacy in supporting U.S. vaccination efforts through the domestic manufacturing of needles and syringes.

“As the fight against COVID-19 continues, we are steadfast in our commitment to securing the nation’s supply continuity of these critical injection devices,” said Rick Byrd, president of Medication Delivery Solutions for BD. Our teams are working tirelessly – as they have been since the beginning of the pandemic – to ensure that all of our customers, including the U.S. government, have the supplies they need to vaccinate against this virus while simultaneously managing routine, preventative health care needs, such as the seasonal flu.

The new lines increase capacity of BD’s existing needle and syringe supply capabilities domestically. To date, the company has provided several hundred million injection devices to the federal campaign. This marks a timely manufacturing milestone as the United States heads into flu vaccination season and the critical need for these essential devices continues.

“Domestic manufacturing has proven critical to responding rapidly and effectively to this pandemic,” said Dawn O’Connell, HHS Assistant Secretary for Preparedness and Response. “With millions of lives at stake, we do not have time to wait for supplies to be shipped from other countries. Taking action now to increase U.S.-based manufacturing capacity will allow us to meet the needs of patients and health care providers while also creating valuable U.S. jobs.

Increasing supply capacity from the company’s Holdrege facility builds on a 70-year manufacturing legacy in the state. BD operates three other world-class manufacturing facilities in Nebraska: Broken Bow and two facilities in Columbus. The company first established its manufacturing presence in Nebraska following World War II to support the U.S. government’s call for the geographic diversification of manufacturing operations away from the East Coast. Since then, BD’s 3,500 Nebraska-based employees have been motivated by the promise and power of ensuring providers on the front lines of health care have access to needed injection devices. That motivation inspired the development of these new manufacturing lines, as demonstrated in this brief video.

In addition to ramping up the manufacturing of needles and syringes domestically to meet U.S. needs for the COVID-19 pandemic, BD is working to help ensure the global community is prepared for future pandemic vaccination. BD previously announced plans to invest $1.2 billion over four years to enhance its manufacturing capacity and technology for pre-fillable syringes and advanced drug delivery systems – allowing for continued growth of new injectable drugs and vaccines.

“Among other important lessons learned, COVID-19 is highlighting the critical value of ongoing partnerships, collaboration and planning to meet our nation’s current and future pandemic needs,” said Nicolette Louissaint, PhD, executive director of Healthcare Ready. “We’re proud to partner with BD as they swiftly stepped up and stepped in to help the U.S. increase its capacity to produce syringes and needles that are essential for accelerating vaccination efforts to protect the public here and across the world.”

BD is the largest manufacturer of injection devices in the world, producing multiple billions of syringes and needles annually through its global manufacturing network. To learn more about BD’s vaccination preparedness efforts, visit bd.com/vaccination.

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to accurately detect disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.