Raindrop Near Vision Inlay Reshapes Cornea to Help Eye Focus

Raindrop Near Vision Inlay Reshapes Cornea to Help Eye Focus

The FDA issued approval to ReVision Optics, a company out of Lake Forest, CA, for its Raindrop Near Vision Inlay, a device designed to reshape the cornea to help people with presbyopia see nearby objects. The tiny hydrogel device is implanted in an outpatient procedure. It looks like a contact lens, but is only 2mm in width and 32 micrometers in thickness. A laser is used to create a flap within the cornea and position the Raindrop under it. The new shape of the cornea helps the eye adjust and focus, essentially doing something that a healthy eye should be doing on its own. It was tested in a clinical trial of almost 400 people who received the implant, demonstrating that 92% of patients who were evaluated had 20/40 or better vision at near distances two years after the procedures. It’s intended for people 41 to 65 years old who have not had cataract surgery, but who really don’t like wearing reading glasses. Here’s a promo video for a clinical trial involving the Raindrop: Flashback: The PRESBYLENS Corneal Inlay: An Adjustable Device for Presbyopia… Product page: Raindrop Near Vision Inlay… Via: FDA… The post Raindrop Near Vision Inlay Reshapes Cornea to Help Eye Focus appeared first on...
RESECTR, a New Fully Mechanical Tissue Resection Device

RESECTR, a New Fully Mechanical Tissue Resection Device

Distal Access, a company with offices in Utah and Florida, is now offering a new tissue resection device that has just been used for the first time to remove a uterine polyp. The RESECTR is a fully mechanical device that doesn’t require an external generator or any other capital equipment. It’s powered by the surgeon via the trigger on the handle, which spins the blades on the tip that cut into the tissue. This supposedly provides more control and feel when the mechanism is activated over electronically powered devices. Using the RESECTR the surgeon can see and operate on the target tissue at the same time. Dr. Keith Isaacson at the Newton-Wellesley Hospital in Newton, MA, the first person to use the device, said, “We need safe, accurate, and effective medical devices to perform uterine polyp resection,” said Dr. Isaacson. “The RESECTR is a simple manual surgical instrument that allowed me to target and efficiently remove the polyp during this procedure. It provides a benefit to patients in that the entire polyp can be removed under direct visualization in a very short period of time without the risk of bleeding or uterine perforation.” Product page: RESECTR… Via: Distal Access… The post RESECTR, a New Fully Mechanical Tissue Resection Device appeared first on...
Spanner Prostatic Stent, an Alternative to Foley Catheters, Approved in Europe

Spanner Prostatic Stent, an Alternative to Foley Catheters, Approved in Europe

SRS Medical Systems (Feeding Hills, MA) landed CE Mark approval for its Spanner temporary prostatic stent for men with bladder outlet obstructions, an option over Foley and intermittent catheters commonly used these days. The device is placed within the urethra at the neck of the bladder, but unlike the Foley it lets patients urinate voluntarily, in many cases completely normally without feeling like there’s an internal mechanism helping it happen. This is thanks to a design that relies on the patient’s own external sphincter muscle of urethra to regulate the flow of urine through the device. The Spanner can be placed in an office setting without requiring any imaging in a fairly rapid procedure. The device can be removed in a reverse procedure utilizing a retrieval tether. It’s already approved in the U.S. for up to 30 days of continuous use and a study is being conducted that may lead to expansion of its indications. Here’s a video explaining the Spanner:   Product page: Spanner Prostatic Stent… Via: SRS Medical… The post Spanner Prostatic Stent, an Alternative to Foley Catheters, Approved in Europe appeared first on...
Avitus Bone Harvester Device Cleared by FDA in USA

Avitus Bone Harvester Device Cleared by FDA in USA

Avitus Orthopaedics, a company out of Farmington, Connecticut, received FDA clearance and has begun sales of its Avitus Bone Harvester device for gathering autologous bone graft and bone marrow. The device allows physicians to gather autografts in a minimally invasive fashion, which serves as probably the best material for orthopedic procedures. The firm is now working on winning European regulatory approval later on this year. “We are excited for the feedback and enthusiasm we have received from surgeons piloting our technology,” said Neil Shah, CEO of Avitus. “This validates the need for a streamlined way to obtain significant volumes of cancellous autograft and bone marrow. Autograft is regarded as the gold standard bone graft material; our technology has the potential to mitigate the harvesting challenges associated with autograft and provide a cost effective solution for surgeons using this bone graft option.” Product page: Avitus Bone Harvester… Via: Avitus Orthopaedics… The post Avitus Bone Harvester Device Cleared by FDA in USA appeared first on...
AtriClip PRO2 LAA Occlusion System Cleared in Europe

AtriClip PRO2 LAA Occlusion System Cleared in Europe

AtriCure, a company out of Mason, Ohio, obtained CE Mark permission to introduce its AtriClip PRO2 left atrial appendage (LAA) exclusion system. Already approved by the FDA, the device is used to resect the LAA via a minimally invasive procedure. The new device is designed for easy operation with either hand, allowing for easier pitch and yaw movement when aligning the end effector with the LAA. The end effector is hoopless, allowing for better visualization of the target and for easier removal of the device once the clip is applied. Here’s an animation showing how the AtriClip PRO2 is used in preparation for an aortic valve replacement: Flashback: AtriCure’s AtriClip PRO2 Left Atrial Appendage Occlusion System FDA Cleared… Product page: AtriClip PRO2… Via: AtriCure… The post AtriClip PRO2 LAA Occlusion System Cleared in Europe appeared first on...