Medical Devices

Baystate Health First in U.S. to Enroll Patients in PIONEER Aneurysm Trial

Springfield, Mass. – September 26, 2026 -- Baystate Health has become the first hospital in the United States to enroll patients in the PIONEER trial, a national study evaluating Balt Corporation's Silk Vista Baby flow-diverting stent for unruptured brain aneurysms in small blood vessels, treating its first three patients within days of receiving approval.

Baystate enrolls first three U.S. patients in national aneurysm device trial

The PIONEER study is a prospective, multicenter, single-arm trial spanning 35 leading centers in the United States and 5 in Canada, designed to assess the safety and efficacy of the Silk Vista Baby device. Balt Corporation launched the trial to satisfy FDA requirements for broader U.S. market access after the device received full approval from the Centers for Medicare & Medicaid Services following a prolonged review process.

BRIJ Medical Study: Zero Complications in 100 Orthopedic Cases

San Diego – September 22, 2026 -- BRIJ Medical reported zero documented cases of wound dehiscence, infection, allergic dermatitis, adhesive-related skin injury or wound-related reoperation across a 100-case retrospective study of its Brijjit Force-Modulating Tissue Bridges in sports medicine incision management.

Single-surgeon study spans three years of orthopedic procedures

The study, published in the Journal of Orthopaedic Experience & Innovation (Volume 7, Issue 2), evaluated 100 consecutive outpatient sports medicine procedures performed by a single surgeon, John A. Grotting, MD, between January 2023 and December 2025. Cases spanned ACL, knee, shoulder, elbow and ankle procedures, with co-author Ege Karadag.

SirPAD Trial Subgroup Data on Sirolimus Balloon Set for VIVA 2026

Las Vegas – September 21, 2026 -- Concept Medical's MagicTouch sirolimus-coated balloon will face fresh scrutiny at VIVA 2026 as researchers unveil new subgroup data from the SirPAD randomized trial covering 597 patients treated for femoropopliteal peripheral artery disease without tissue loss.

SirPAD enrolled 1,252 patients to compare drug-coated and uncoated balloon angioplasty

The academic, investigator-initiated trial randomized 1,252 patients with symptomatic infrainguinal peripheral artery disease to angioplasty using either the MagicTouch PTA sirolimus-coated balloon or an uncoated balloon. Primary results, published in the New England Journal of Medicine, showed the sirolimus-coated balloon arm was both non-inferior and superior to the uncoated balloon on major adverse limb events (MALE) at one year.

InventHelp Client Unveils Patient Repositioning Device for Licensing

Pittsburgh – September 19, 2026 -- An inventor from Brooklyn, N.Y., has developed a device called NURSES WEEKEND designed to reduce injury risk when repositioning patients in hospital and care beds, according to InventHelp, which submitted the design and is now seeking a manufacturing or marketing partner.

Device targets injury risk in routine patient care tasks

The invention provides a mechanism to move patients in bed for tasks such as changing linens, performing hygiene care, and preventing pressure sores. Its adjustable design is intended to reduce physical strain on medical professionals and caregivers while improving patient comfort and safety.

Q'Apel Launches Lynx Aspiration Catheter for Stroke Thrombectomy in US

Fremont, Calif. – September 15, 2026 -- Q'Apel Medical has launched the Lynx Aspiration Catheter System in the United States, expanding its neurovascular portfolio into the aspiration category for mechanical thrombectomy, the standard of care for acute ischemic stroke caused by vessel occlusion.

Lynx becomes the second Q'Apel product built on proprietary QLCT technology

The Lynx system marks the second device to feature Q'Apel's proprietary Q'Apel Laser Cut Tube (QLCT) technology, following the company's earlier product on this engineering platform. The catheters use a bimetal shaft design with an open-spaced nitinol structure intended to balance proximal support with distal flexibility while resisting kinking during navigation through complex cerebrovascular anatomy.