Product News

clinical outcomes,” said Chris Mansi, CEO of Viz.ai. “The feedback from our early adopters has been highly positive, and we look forward to expanding access to this solution to our over 1,300 hospital customer base.”

New data presented at VEITHsymposium a lower profile and a soft, atraumatic tip designed to help navigate the complex and delicate anatomy of the body. When used together, the device is intended to help remove blood clots quickly while minimising potential blood loss. and provides more consistency in the procedure. We believe that the Vesseal will support enhanced outcomes in microsurgical procedures, as well as improved patient care.”

Viz.ai launches AI-powered Viz Vascular Suite

Viz.ai has announced the launch of Viz Vascular Suite—artificial intelligence (AI)-powered software enabling vascular care teams to automatically detect and triage care for suspected pulmonary embolism, right heart strain, aortic dissection, and abdominal aortic aneurysm (AAA). The company submitted a new 510(k) application to the US Food and Drug Administration (FDA) for the AAA algorithm, a press release notes.

“Recognising the symptoms of serious vascular conditions, such as aortic dissections, is hugely important because any delay in treatment can have a direct impact on patient outcomes,” said Philip Batista (Cooper University Health Care, Camden, USA). “When Viz identifies an abnormal scan, it quickly notifies the appropriate specialists regardless of their location, facilitating seamless communication via mobile application. We have been using the Viz software for the last several months and have seen improvements in patient care across our institution.”

Viz.ai claims that the Viz Vascular Suite uses AI to automatically analyse an array of imaging modalities, including computerised tomography (CT), electrocardiogram (ECG), and more for suspected vascular diseases. If a suspected pathology is found, the app automatically alerts and displays high-fidelity patient scans on providers’ mobile devices. Clinicians can use Viz Vascular Suite to remotely co-ordinate vascular pathology care within a hospital system’s hub and spoke network and enable synchronous, HIPAA-compliant communication among specialists. The platform is enhanced by AI for immediate team activation and facilitates informed, efficient treatment decisions.

“We set out to build a solution where any patient with life threatening diseases can benefit from AI-powered care coordination with triage and real-time mobile communication.

The Viz Vascular Suite will bring the advantages of intelligent care coordination to even more patients and help clinical teams achieve better

The launch follows Viz.ai’s announcement late last year of new data from a large aortic dissection artificial intelligence (AI) real-world study that support the use of the company’s AI technology for the detection of suspected aortic dissection. Data from the new study were presented at VEITHsymposium 2022 (15–19 November, New York, USA).

Penumbra launches Lightning Flash mechanical thrombectomy system

Penumbra recently announced the US Food and Drug Administration (FDA) clearance and launch of its Lightning Flash mechanical thrombectomy system.

“Lightning Flash features Penumbra’s novel Lightning intelligent aspiration technology, now with dual clot detection algorithms,” the company notes in a press release, adding that the system is designed to quickly remove large blood clots in the body, including venous thrombus and pulmonary emboli (PE).

“Penumbra’s Lightning Flash gives physicians a highly torqueable, larger catheter that is designed to remove a large clot burden in the pulmonary arteries or deep venous system more efficiently while maintaining an excellent safety profile because of Lightning’s computer-aided algorithms,” said James F Benenati, chief medical officer at Penumbra. “We believe that patients can have improved outcomes with this new technology because of the exceptional trackability and unique ability to distinguish flowing blood from clot.”

The company details that Lightning Flash, powered by the Penumbra Engine, uses both pressure and flowbased algorithms to detect blood clot and blood flow. The catheter is made with MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining

“Lightning Flash will fundamentally change how blood clots are removed from the body,” said Adam Elsesser, president and chief executive officer of Penumbra. “With this latest advancement, physicians are more likely to adopt mechanical thrombectomy because a broad spectrum of blood clots can be removed much quicker and less invasively than current interventional or surgical methods. This means that we are able to help even more patients with our technology, which is core to who we are as a company.”

Lightning Flash is part of Penumbra’s Indigo system with Lightning portfolio. The company claims that Lightning products are the only computer-aided mechanical thrombectomy systems currently available in the USA and early data have shown improvement in clinical outcomes and quality of life.

Lydus Medical announces US FDA clearance of microvascular anastomosis aid device

Lydus Medical has announced that the Vesseal has received US Food and Drug Administration (FDA) 510(k) clearance. The Vesseal is a microvascular anastomosis suture deployment system, for standardised omnivessel anastomoses, enabling simple, fast, safe, and effective procedures.

An anastomosis is one of the most complicated steps of microvascular surgery and fundamental to the success of these demanding surgical interventions. Varied clinical fields require microvascular anastomosis, including breast reconstruction; head and neck reconstruction; surgical lymphoedema treatment; and vascular access for haemodialysis.

Until now, microvascular anastomoses have been performed manually. Manual microanastomoses are time- and labour-intensive, require a long learning curve, a unique skillset and great surgical dexterity. The Vesseal is designed to mimic the skillset and dexterity needed to deliver quality patient care in microsurgical anastomoses. It provides simple, accurate, dependable and consistent results through symmetrical placement of eight microsutures at the anastomosis site.

“FDA clearance of the Vesseal is a significant milestone both for innovation in microvascular anastomoses, and for Lydus Medical. It is common knowledge that there are large clinical unmet needs around microvascular anastomosis,” said Jessica Weiss, CEO of Lydus Medical. “Clinicians who used the Vesseal stated that it shows a significant advantage over the manual anastomosis

Funding secured to advance development of Pulse IVL system

AVS has announced that it raised US$20 million in Series B financing, which the company says will accelerate clinical trial timelines for its device for peripheral application in pulsatile intravascular lithotripsy (PIVL) cases and advance development and preclinical work on a PIVL device for coronary cases.

BioStar Capital, the lead investor in the company’s Series A round, also led the Series B round. BioStar Capital is focused on transformational investments in medical technologies with an emphasis on cardiovascular and orthopaedics.

“AVS is one step closer to offering a new treatment solution for patients with severely calcified peripheral arterial disease and progressing toward preclinical studies for coronary cases,” said Mark Toland, managing director for BioStar Capital and executive chairman/CEO of AVS. “Patients in this disease state too often face the prospect of limb amputation due to a lack of treatment options. We see a significant opportunity to address that need and advance the intravascular lithotripsy space through minimally invasive technology in both peripheral and coronary therapy.”

AVS’s novel balloon-based platform, the Pulse IVL system, shatters calcium with pressure waves in frequent bursts and expands calcified arteries, all with a single device.

“We are proud to support AVS in both its successful Series A and Series B funding rounds,” said Louis Cannon, founder and senior managing partner of BioStar Capital. “The preclinical results of the Pulse IVL System have shown the potential to raise the standard of care and significantly impact the wellbeing of patients with calcified arterial disease. We are excited to partner with AVS as it looks to future clinical trials and development.”

In September 2022, AVS announced enrolment, successful treatment, and positive 30-day follow-up data of the first patients in its POWER PAD I clinical trial, a first-in-human study. Jon George (University of Pennsylvania Health System, Philadelphia, USA) an interventional cardiologist and medical advisor to AVS, assisted in trial cases in the Dominican Republic.

“Our early trial results showed that we can successfully treat patients with multiple lesions using a single device,” said George. “We saw patients report a reduction in leg pain, increase in blood flow to the leg, and improvement in their ability to walk in our initial study.

This is a patient population that needs easier access to advanced therapies and this platform has the potential to provide that access.”