FDA clears computer-assisted thrombectomy system from Penumbra

The Lightning Flash 2.0 computer-assisted thrombectomy system. [Image courtesy of Penumbra]Penumbra (NYSE:PEN) announced today that it received FDA clearance for and began the launch of its Lightning Flash 2.0 CAVT system.

Lightning Flash 2.0 represents the next generation of the company’s computer-assisted vacuum thrombectomy (CAVT) technology. It removes the venous thrombus to treat pulmonary emboli (PE).

The system features Lightning Flash algorithms designed for increased speed and sensitivity to thrombus and blood flow. Combined with Penumbra’s novel catheter technology, the new advancements help to better navigate the patient’s anatomy. This helps to deliver high power for clot removal with possible minimal blood loss.

Dr. James F. Benenati, chief medical officer at Penumbra said the company already has positive feedback from its initial launch. Early reports showed improved procedure time through shortened aspiration time, plus redu…

Read more
  • 0

First patient enrolled in Penumbra study of computer-assisted vacuum thrombectomy

The Lightning Flash system. [Image courtesy of Penumbra]Penumbra (NYSE:PEN) today announced the first patient enrolled in STORM-PE, a trial of its Lightning Flash thrombectomy system.

Lightning Flash, a mechanical thrombectomy system, received FDA clearance in January. The system features Penumbra’s novel Lightning intelligent aspiration technology with dual-clot detection algorithms. Combining it with innovative catheter engineering, Penumbra designed Lightning Flash to quickly remove large blood clots, including venous thrombus and pulmonary emboli (PE).

This combination can differentiate between clot and blood. Its design, which helps reduce blood loss and the need for clot-dissolving drugs, may lower the risk of bleeding complications.

The trial evaluates anticoagulation alone against anticoagulation plus Lightning Flash for the treatment of PE. STORM-PE, a first-of-its-kind, multi-center, randomized controlled trial, aims to advance the understan…

Read more
  • 0

Patient-centered VR design fuels Penumbra’s Immersive Healthcare future

Penumbra President of Immersive Healthcare Gita Barry [Image courtesy of Penumbra]

Penumbra is leveraging virtual reality to transform how patients interact with their care, offering therapeutic devices that give clinicians the tools to monitor and enhance therapy outcomes.

The company’s immersive healthcare division is developing virtual reality (VR) technology to enhance patient care. The REAL system gives clinicians tools to monitor patient progress, improve engagement and enhance satisfaction during rehabilitation, as well as address cognition and mental wellbeing. By integrating VR technology with patient-centric design principles, Penumbra aims to transform the therapy experience.

“It’s a really different point of view. It’s leveraging the perspective of Penumbra versus a lot of the other companies that are in the space,” Penumbra Immersive Healthcare President Gita Ba…

Read more
  • 0

March 2023 Issue: Incredible enabling technologies



Stryker on steroids: How enabling technology will supercharge surgical robotics

How Penumbra’s smart-sucking algorithms and catheters speed up clot removal

What Abbott learned about COVID-19 and cardio devices

Genascence believes gene therapy can transform the treatment of knee osteoarthritis

What to expect in diabetes care in 2023

Incredible enabling technologies

The FDA has cleared or approved more than 500 devices enabled by artificial intelligence (AI) or machine learning, and the list keeps getting longer.

Medtech AI is helping physicians diagnose, treat and monitor patients like never before. Sometimes the software works as a medical device all on its own. But the real fun starts when device developers pair software with other enabling technologies like robotics, miniaturization, 3D printing and advanced materials.

For example, take Stryker…

Read more
  • 0

Penumbra grows sales 8% in Q4

Penumbra (NYSE:PEN) this week posted fourth-quarter results that beat the overall consensus on Wall Street.

The Alameda, California-based company — maker of interventional devices for vascular and neuro therapies — reported profits of $3.9 million, or 10¢ per share, on sales of $221.2 million, for the three months ended Dec. 31, 2022. Sales were up 8.43% compared with Q4 2021. Penumbra reported $24.6 million in losses a year ago.

Adjusted to exclude one-time items, earnings per share were 16¢, 1¢ ahead of The Street, where analysts were looking for sales of $217.03 million.

“Our journey to develop the most optimal solution for safe, effective, fast and powerful removal of blood clot wherever it resides in the body is nearly two decades in the making. And the early results from the use of Lightning Flash in venous and PE patients and Thunderbolt in our stroke trial is giving us even more confidence that the computer-orchestrated aspiration is changi…

Read more
  • 0

FDA clears Lightning Flash thrombectomy system from Penumbra

[Image courtesy of Penumbra]Penumbra (NYSE:PEN) announced today that it received FDA clearance for the Lightning Flash mechanical thrombectomy system.

Alameda, California-based Penumbra also initiated the launch for the system. The company called Lightning Flash “the most advanced and powerful mechanical thrombectomy system on the market.”

Lightning Flash features the company’s novel Lightning intelligent aspiration technology with dual-clot detection algorithms. Combining it with innovative catheter engineering, Penumbra designed Lightning Flash to quickly remove large blood clots. This includes 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…

Read more
  • 0

FDA clears Lightning Flash thrombectomy system from Penumbra

[Image courtesy of Penumbra]Penumbra (NYSE:PEN) announced today that it received FDA clearance for the Lightning Flash mechanical thrombectomy system.

Alameda, California-based Penumbra also initiated the launch for the system. The company called Lightning Flash “the most advanced and powerful mechanical thrombectomy system on the market.”

Lightning Flash features the company’s novel Lightning intelligent aspiration technology with dual-clot detection algorithms. Combining it with innovative catheter engineering, Penumbra designed Lightning Flash to quickly remove large blood clots. This includes 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…

Read more
  • 0

Penumbra launches VR-based rehab platform

The REAL y-Series full-body, non-tethered immersive healthcare offering for rehabilitation. [Image from Penumbra]Penumbra (NYSE:PEN) announced today that it launched a full-body, non-tethered immersive healthcare offering for rehabilitation.

Alameda, California–based Penumbra designed its REAL y-Series product with lower and upper body sensors. They allow clinicians to track full-body movement and progress in real-time.

By expanding its virtual reality-based immersive healthcare platform, Penumbra plans to support a broad range of patients. According to a news release, these patients undergoing physical or occupational therapy could improve their physical, cognitive and mental well-being.

“Two of the largest challenges in rehabilitation are maintaining patient motivation and lack of engagement,” said Gita Barry, EVP and GM of Penumbra’s Immersive Healthcare business. “Penumbra’s latest REAL y-series is the only hands-free, sensor-based VR platform available…

Read more
  • 0

Penumbra launches RED reperfusion catheters in Europe

[Image from Penumbra]Penumbra (NYSE:PEN) announced today that it received CE mark for its RED reperfusion catheter and began its European launch.

Alameda, California-based Penumbra designed its RED reperfusion catheter for the removal of all clot types in acute ischemic stroke (AIS) patients. Recent data presented by the company demonstrated successful revascularization using the RED system.

Get the full story at our sister site, Medical Tubing & Extrusion.

Read more
  • 0

Join us at DeviceTalks West, the World’s Fair of Medtech

Intuitive Surgical CEO Gary Guthart will participate in a keynote interview at DeviceTalks West 2022. [Photo courtesy of Intuitive Surgical]

October’s DeviceTalks West conference is focused on the future.

The best-seller “Devil in the White City” may have darkened the perception of world’s fairs, but these international convocations have long presented visitors with an optimistic and hopeful view of the future, thanks in no small part to new technology. (The next one is scheduled for 2025 in Osaka, Japan, by the way.)

I like to think we’ll be following similar guidelines at the upcoming DeviceTalks West conference, which will be held on Oct. 19-20 at the Santa Clara Convention Center.

This event will bring together executives from Abbott, Boston Scientific, Edwards Lifesciences, Intuitive, Johnson & Johnson, Medtronic, Outset Medical, Penumbra, Shockwave, Zimmer Biomet and many …

Read more
  • 0

Data backs Penumbra’s catheters for stroke care

[Image from Penumbra]Penumbra (NYSE:PEN) announced today that initial data support the use of its RED reperfusion catheters and the Penumbra System.

Alameda, California-based Penumbra presented results from the initial Insight Registry for the RED reperfusion catheters and the sub-analyses of the Complete study study for the Penumbra system at the 2022 World Federation of Interventional and Therapeutic Neuroradiology (WFITN) in Kyoto, Japan.

Get the full story at our sister site, Medical Tubing & Extrusion.

Read more
  • 0

Penumbra posts mixed-bag Q4 results, grows sales 22%

Penumbra (NYSE:PEN) this week posted fourth-quarter results that beat the revenue consensus on Wall Street but missed earnings estimates.

The Alameda, California-based company reported losses of -$24.6 million, or -66¢ per share, on sales of $204 million for the three months ended Dec. 31, 2021, for a sales growth of 22.24% compared with Q4 2020.

Get the full story on our sister site, Medical Tubing + Extrusion.

Read more
  • 0