Product News

from Vascular News 98 – June 2023 US Edition

Clinical News

arteriovenous (AV) access in haemodialysis.

Penumbra launches new Red 43 reperfusion catheter for mechanical thrombectomy

Penumbra recently announced the launch of the latest addition to its Red family of catheter devices for mechanical thrombectomy, the Red 43 reperfusion catheter.

According to the company, this device is intended to take distal aspiration “to the next level” with optimised lumen occupation as well as a soft distal design that allows for enhanced and compliant delivery in tortuosity.

With a 0.043-inch lumen, Red 43 provides powerful distal aspiration alongside the Penumbra Engine and features Redglide technology as part of its advanced hydrophilic coating for smooth trackability.

As per the company’s website, additional features of this newly launched device include:

A 1.52mm (0.060-inch) outer dimension: low profile and atraumatic design for distal deliverability

Precision tip: articulating marker band with short polymer tip design for optimal visualisation and placement

Full-length polytetrafluoroethylene (PTFE) liner: designed for durability and lumen integrity under powerful aspiration

Proximal hybrid stainless steel and nitinol coil wind: engineered to provide optimal support and softer profile atraumatic navigation

Humacyte’s

HAV receives

US FDA’s Regenerative Medicine Advanced Therapy designation for urgent arterial repair

Humacyte has been recently granted the US Food and Drug Administration’s (FDA) Regenerative Medicine Advanced Therapy (RMAT) designation for its Human Acellular Vessel (HAV) for urgent arterial repair following extremity vascular trauma.

The US FDA’s RMAT designation is for breakthrough therapy of regenerative medicine. The designation allows for more interactions with the US FDA and expedited development and review of regenerative medicine products within the USA, including the potential for a priority review process for a Biologics License Application (BLA). This is the second RMAT designation granted by the US FDA for Humacyte’s HAV, in addition to a previous RMAT granted for

“We are delighted to receive our second RMAT designation from the [US FDA],” said Cindy Cao, chief regulatory officer at Humacyte. “The RMAT designation for the HAV in our lead indication of vascular trauma is an important milestone. This designation will further enhance our communication with the US FDA and will provide us with a higher likelihood for an expedited review of our planned upcoming BLA filing.”

Humacyte’s HAV is designed to be a universally implantable vascular conduit for use in vascular repair. Importantly, the HAV has shown a low rate of infection in clinical trials, making it well-suited for use in settings such as vascular trauma where wounds may be contaminated with foreign material. The HAV is designed to be available off the shelf and ready whenever surgeons need it, potentially saving valuable time and potentially improving patient outcomes in cases requiring urgent vascular repair, for both civilians and military personnel.

Humacyte is nearing the completion of enrolment in its Phase 2/3 V005 clinical trial of the HAV in the repair of civilian vascular trauma, a study that is being conducted at level 1 trauma centers in the USA and Israel. Currently, a total of 66 patients have received the HAV in the V005 trial, including 49 patients belonging to the primary endpoint population. Humacyte plans to file a BLA with the US FDA later in 2023.

The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency, Humacyte advises.

(University Hospital Innsbruck, Innsbruck, Austria). Terumo Aortic details that Moore was able to access the device through the Health Canada Special Access programme.

The lead centre in Europe for this hybrid procedure, the company states, is the University Heart Center in Hamburg, Germany, under the direction of Sebastian Debus.

Moore commented: “This unique hybrid graft was designed through Terumo Aortic’s custom device programme, specifically for the patient we were treating. With no other device with similar technology currently available globally for thoracoabdominal aortic repair, the Thoracoflo graft is designed to reduce the risk of complications associated with thoracotomy and extracorporeal circulation. This is the first time the device has been implanted in North America; it was easy to implant, and the procedure was uneventful and straightforward. The patient is recovering well with no complications postoperatively.”

John Canning, chief technology and marketing officer at Terumo Aortic said: “This expansion into North America represents a significant commitment to developing patient-specific solutions to treat a wider group of patients as part of our comprehensive surgical, endovascular and hybrid portfolio.”

Terumo Aortic relays that Thoracoflo incorporates a combination of Terumo Aortic’s Gelweave woven polyester grafts and ring-stent technology to fit the patient’s specific anatomy.

Surmodics announces successful first patient use of Sublime radial access microcatheter

Surmodics has announced that Ankur Lodha (Cardiovascular Institute of the South, Lafayette, USA) and Pradeep Nair (Cardiovascular Institute of the South, Houma, USA) were the first physicians to use the company’s Sublime radial access microcatheter.

The Sublime microcatheter is in limited market evaluation, a press release notes. The full suite of Sublime microcatheters will be launched in 2024. The Sublime portfolio will include the industry’s first suite of 0.014”, 0.018”, and 0.035” highperformance peripheral microcatheters.

200cm and compatible with 0.014”, 0.018”, and 0.035” guidewires, the press release details that the Sublime microcatheter is made with Surmodics’ Pristyne hydrophilic coating for lubricity to optimise device trackability through vessel tortuosity. The device’s dual stainless steel, locked-braid layers work in unison to optimise torque control, and to push transmission, and deliverability to distal target lesions, the company adds. The microcatheters are available in straight or angled tip configurations. The Sublime 0.014” and 0.018” microcatheters can be telescoped through the 0.035” Sublime microcatheter to provide additional back-up support when navigating extreme tortuosity or heavily stenosed lesions, the press release continues.

“This successful first use of our Sublime microcatheters is a major milestone, not only for Surmodics, but for the countless patients who stand to benefit from peripheral arterial treatment,” said Gary Maharaj, president and CEO of Surmodics. “For years, torqueable microcatheters have enabled coronary operators to overcome the most extreme challenges presented by complex arterial disease. We are pleased to bring this industry-first capability to peripheral interventions.”

Getinge receives US FDA premarket approval for the iCast covered stent system

Getinge’s iCast covered stent system has received premarket approval from the US Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.

Iliac arterial occlusive disease is a type of peripheral arterial disease (PAD), which affects 8 million people in the USA. As the world population ages and rates of diabetes and obesity rise, it is estimated that more people will be affected with iliac artery disease.

Terumo Aortic announces first implant of custom-made thoracoabdominal hybrid device in North America

Terumo Aortic recently announced the first North American implant of a custom-made hybrid device, Thoracoflo. A press release notes that the device is used to treat patients with thoracoabdominal aortic disease using a less invasive surgical technique than traditional open surgical repair.

This thoracoabdominal repair procedure using Thoracoflo was carried out by Randy Moore (University of Calgary, Calgary, Canada). Moore and the team at University of Calgary were supported by Sabine Wipper

“For peripheral as well as coronary interventions, radial access is safer than femoral access and much preferred by patients,” said Lodha. “I am pleased to report that the Sublime microcatheter performed exceptionally well during our first uses of the device in treating peripheral arterial disease.”

“The lack of long-length, highperformance catheters for peripheral procedures has slowed adoption of radial access for treatment of lower extremity artery disease,” added Nair. “Sublime microcatheters will fill a major gap in the peripheral intervention toolkit, including for procedures from access sites other than the wrist.”

Available in five lengths from 65 to

“We are pleased that the iCast stent system is approved in the USA for use in iliac arteries to benefit an even greater number of patients,” says Elin Frostehav, president of acute care therapies at Getinge. “The global market for covered stents is growing at an annual rate of 5%. Getinge will continue to ramp up capacity throughout the year in order to meet the demand.”

The iCast covered stent system, which is sold outside the USA under the brand name Advanta V12, has been used by clinicians for 20 years and is the most clinically evaluated balloon expandable polytetrafluoroethylene (ePTFE)-covered stent in the world, with clinical data published in more than 550 articles.

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