This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are 7 medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press […]
Clinical Trials
Clearside inks clinical development deal with EyeKor
Clearside Biomedical (NSDQ:CLSD) said today that it landed a deal with EyeKor Inc. to support its clinical trials. The companies did not disclose any financial details of the agreement. Clearside is conducting a Phase III trial of suprachoroidally administered CLS-TA, its suspension formulation of triamcinolone acetonide, in patients with macular edema associated with non-infectious uveitis. The […]
Merck, Avillion ink development deal for nanobody psoriasis treatment
Merck KGaA and Avillion inked a clinical co-development deal today for Merck’s anti IL-17 A/F Nanobody therapy for plaque psoriasis. The financial terms of the deal were not disclosed. The investigational treatment underwent Phase I development and the group plans to initiate Phase II trials this year. According to the terms of the agreement, Avillion […]
Medtronic launches Arctic Front cryoablation PVI study
Medtronic (NYSE:MDT) said today it enrolled the 1st patient in the Stop Persistent AF clinical trial of its Arctic Front Advance cardiac cryoablation catheter. The 225-patient, 12-month trial aims to explore the effectiveness and safety of pulmonary vein isolation-only treatments for patients with persistent atrial fibrillation using the Arctic Front Advance cryoablation catheter, the Fridley, […]
Acorda plans NDA for inhaled Parkinson’s drug after touting long-term safety data
Acorda Therapeutics (NSDQ:ACOR) touted data from 2 ongoing, long-term safety studies of its inhaled Parkinson’s therapy. The trials showed no difference in pulmonary function between the group receiving CVT-301, the inhaled formulation of Parkinson’s drug levodopa, and the control group. The investigational drug is being studied as a therapy for people with Parkinson’s disease experiencing “off” […]
Cardiovascular Systems launches combined Diamondback 360, DES trial
Cardiovascular Systems (NSDQ:CSII) said today it enrolled the 1st patient in the Eclipse clinical trial of its Diamondback 360 coronary orbital atherectomy system. The St. Paul, Minn.-based company is looking to enroll 2,000 patients in the trial which aims to explore the use of the Diamondback 360 device for treating patients with severely calcified coronary lesions […]
Study: Neuro-implants restore motion to quadriplegic patient’s arm
A quadriplegic man has had limited motion restored to his arm and hand as a result of a novel neuro-prosthesis connected to electrical stimulators in his arm, according to a new study. The 53-year old patient, who was paralyzed from below the shoulders for 8 years as a result of a bicycle accident, has had […]
RepliCel touts tendon regeneration data for its fibroblast therapy
RepliCel Life Sciences (OTC:REPCF) touted data this week from its Phase 1/2 tendon repair study evaluating its type I collagen-expressing, hair follicle-derived fibroblasts as a treatment for Achilles tendinosis. The clinical trial established a complete safety profile for RepliCel’s RCT-01 at 6 months and showed no serious adverse events related to the treatment or injection procedure. […]
Study: Knee replacement surgeries for OA patients less effective, more costly than thought
Knee replacement surgeries for patients with osteoarthritis provide minimal improvements in quality of life and are economically unattractive, according to a study released this week. Results from the study was published yesterday in The BMJ. Data from the study indicated that while the procedure was inefficient for patients with osteoarthritis, its effectiveness would rise if […]
FDA approves 1st-in-human trial for neural-enabled prosthetic hand
The FDA granted an investigational device exemption for the 1st-in-human trial of a neural-enabled prosthetic hand developed at Florida International University, backed by more than $2 million from the U.S. Defense Dept. The device is designed to stimulate nerves in the arm to provide sensation during use. It’s billed as the 1st fully implantable, wirelessly controlled Class-III […]
Burst Biologics to launch spinal fusion trial
Burst Biologics said today that it won regulatory approval to begin a clinical trial evaluating its BioBurst Fluid cellular allograft in spinal fusion patients. The company’s cellular allograft is derived from umbilical cord blood and has yielded promising results in spinal fusion procedures, according to the Boise, Idaho-based company. The prospective trial is slated to […]