SURMODICS PROVIDES REGULATORY UPDATE RELATED TO FDA PREMARKET APPROVAL APPLICATION FOR DCB

SURMODICS RECENTLY ANNOUNCED IT HAS RECEIVED A LETTER from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB).

In the letter, the FDA indicated that the application is not currently approvable, while providing specific guidance as to a path forward. The letter stated that certain information within two general categories—biocompatibility and labelling— must be added by an amendment to the company’s PMA application to place it in approvable form. Although the information identified by the FDA to put the PMA application in approvable form would require additional testing and analysis, the letter did not question the human clinical data submitted nor request any further human clinical data.

“We are disappointed by the FDA’s response to our PMA application and continue to have confidence in our SurVeil DCB including its compelling performance in the TRANSCEND clinical study,” said Gary Maharaj, chief executive officer of Surmodics.

“We are evaluating the issues raised in the FDA’s letter and plan to meet with Agency representatives regarding its contents. Based on our discussion with the Agency, our team and external advisors will determine the appropriate path forward. Concurrently, we will be evaluating options to reduce our use of cash given this development. We expect to address these topics further in connection with our upcoming first quarter fiscal 2023 earnings call.”

Surmodics notes in a press release that the SurVeil DCB is a next-generation device for the treatment of peripheral arterial disease and includes a proprietary drugexcipient formulation using an innovative process to improve coating uniformity. The company advises that, in the U.S., the SurVeil DCB is an investigational device, limited by Federal law to investigational use.

GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*

GERMANY-BASED endovascular device company Bentley announced the launch of the BeBack crossing catheter— formerly known as the GoBack— designed for the treatment of heavily calcified lesions above and below the knee.

Bentley acquired the catheter in September 2022 from Upstream Peripheral Technologies, of Caesarea, Israel. The now-rebranded BeBack crossing catheter is available in an 80cm and 120cm catheter in both 2.9F and 4F sizes. The device makes use of a steerable and in-length adjustable nitinol needle, which can be used for crossing and targeted re-entry purposes. “A radiopaque marker indicates the direction in which the curved needle protrudes from the tip of the catheter. Multiple treatment options like antegrade, retrograde and crossover are possible with the BeBack catheter for intraluminal and subintimal approaches of stenotic or occluded lesions.”

The BeBack is CE marked and Food and Drug Administration (FDA) cleared.

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 Food and Drug Administration (FDA) for the AAA algorithm, a press release notes.

“Recognizing 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, MD, Cooper University Health Care, Camden, New Jersey. “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 says that the Viz Vascular Suite uses AI to automatically analyze an array of imaging modalities, including computerized 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 coordinate 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.

INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts. CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available.

*As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS Heparin Surface. Products listed may not be available in all markets.