industry news

Vapotherm is set to scale up capital equipment manufacturing capabilities to increase the production of its Precision Flow systems.

The move is in response to an anticipated increase in demand for the company’s Precision Flow Hi-VNI system in the event of new waves of Covid-19 pandemic.

The company intends to scale up the production by up to 20x above pre-Covid-19 pandemic levels with additional 350 manufacturing jobs at its New Hampshire, US, facility.

Vapotherm’s Precision Flow Hi-VNI system is an advanced high-flow nasal cannula (HFNC) system, which uses high velocity to treat respiratory distress related to Covid-19 disease.

It offers high flow at a high velocity, rapidly flushing the dead space in the limited time between breaths when respiratory rates are elevated.

A number of public health authorities and medical speciality societies, including Center for Disease Control (CDC), the National Institutes of Health (NIH), the Society of Critical Care Medicine (SCCM) and the American College of Emergency Physicians (ACEP) have recommended HFNC over early invasive mechanical ventilation when possible.

Commenting on the latest development, Vapotherm CEO Joe Army said: “The Covid-19 pandemic has greatly accelerated a process we were already seeing of respiratory experts recognising the benefits of our Precision Flow Hi-VNI system for treating patients with all types of respiratory distress.

“As hospitals and governments across the United States and around the world prepare for potential future waves of Covid-19 patients and subsequent pandemics, involving respiratory disease, we are expanding our manufacturing capabilities to be in a position to meet the needs of hospitals and patients for our therapy.”

Transit Scientific has received the US Food and Drug Administration (FDA) clearance for its XO Score Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform.

The clearance enables the use of the platform in iliac, iliofemoral, popliteal, infra-popliteal and renal arterial, as well as synthetic and native arteriovenous hemodialysis fistula.

The XO Score is a patented, low-profile, flexible, metal-alloy exoskeleton with a balloon-expandable scoring section. It reduces the cost of scoring or cutting procedure.

Expandable polymer balloon catheters are typically used in angioplasty to dilate stenosed or narrowed vessels.

Special scoring or cutting angioplasty balloons with integrated wires or blades on the balloon are required for calcified, fibrous and/or resilient stenosis. The added features improve dilating force while creating large crossing profiles and limited deliverability, which, in turn, increases the cost and inventory.

Transit Scientific’s XO Score sheath can be used with a number of 4mm-8mm diameter and 20mm-40mm long balloons to save the money on each scoring or cutting procedure.

Transit Scientific president Greg Method said: “XO Score transforms regular PTA balloons into scoring and cutting systems.

“Clinicians insert an off-the-shelf PTA balloon into the XO Score tableside and then the system can be used over-the-wire to dilate calcified plaque and prep vessels.”

While typical scoring/cutting balloons feature 1-5 fixed-depth scoring wires / blades that add bulk, profile and stiffness, XO Score has up to 22 scoring / cutting struts that lay flat during tracking.

It rotates 90° during balloon inflation to score and cuts 0.25mm, 0.35mm, or 0.50mm deep and rotates back during deflation.

Last month, Transit Scientific obtained FDA clearance for the XO Cross 2Fr, 2.6Fr and 3.8Fr low-profile microcatheter platform.

LabMinds has closed a fully subscribed funding round from a mix of private and strategic investors for the commercial expansion of its REVO robotic system.

In addition to the commercialisation of its automation system, the company will use the fund to expand its product portfolio.

LabMinds president and CEO Jeff Caputo said: “We are pleased to announce the completion of a fully subscribed funding round.

“We appreciate the support and excitement of our existing and new investors. Not only do they recognise the large market opportunity for this innovative technology, but they also acknowledge the considerable value it brings to the drug development process, especially during these challenging times.”

The Revo system is designed to automate the physical preparation of buffers from solids and liquids, producing error-free solutions.

It enables scientists and researchers to gain time, execute repeatable research and speed up the rate of discovery by optimising lab efficiency and increasing productivity.

The system is currently used by the company’s clients for rapid Covid-19 drug discovery and development.

LabMinds chairman of the board John Kawola said: “Our team at LabMinds continues to build traction within the bio-pharma world with multiple large customers moving toward using the REVO platform to standardise processes.

“Automation in solution preparation has been lacking. The REVO fills this gap and accelerates drug development while saving time and money for our customers. The board and investors are excited to continue to support the company’s growth.”

The company noted that its latest funding round was closed at a 20% higher share price than the funding round completed last year.

Boston Scientific has launched DIRECTSENSE Technology, a tool to monitor the effect of radio frequency (RF) energy delivery during cardiac ablation procedures.

Launched in the US, the tool received US Food and Drug Administration (FDA) approval in April and is available on the RHYTHMIA HDx Mapping System.

It is considered to be the only tool to monitor changes in local impedance – electrical resistance – around the tip of the INTELLANAV MiFi Open-Irrigated (OI) ablation catheter.

Furthermore, the tool provides the clinician with an additional measurement of therapy effect during the ablation procedure.

Physicians use a catheter during the procedure to create lesions and destroy heart tissue that causes abnormal rhythms in patients with cardiac arrhythmias.

DIRECTSENSE Technology provides data on the impedance around the catheter tip to measure the ability of the tissue to respond to RF energy before physicians deliver therapy.

The tool also tracks the change in local impedance and provides physicians with a distinct understanding of tissue characteristics during an ablation. These insights may help to reduce the chances of over-ablation and avoid complications.

Boston Scientific Rhythm Management and Global Health Policy senior vice-president and chief medical officer Kenneth Stein said: “Building upon the success seen with the DIRECTSENSE Technology in Europe, we are pleased to introduce this tool to physicians and their patients in the US.

“This approval marks an exciting milestone for our growing electrophysiology portfolio, providing physicians with a more direct understanding of lesions and procedural efficiency to obtain optimal patient outcomes.”

The company recently received CE Mark for the POLARx Cryoablation System and has plans to launch the product in the coming months.

In December last year, it secured 510(k) clearance from the US FDA for its EXALT Model D duodenoscope.

Meditech Spine has received 510(k) clearance from the US FDA to market a new lumbar plate option CURE Opel-L (S) system.

The system adds on to the company’s previously FDA-cleared CURE LP Plate System and pairs with its Talos-A (HA) Interbody system. The clearance will enable Meditech Spine to offer an Interbody/Plate assembly for the anterior lumbar spine.

The combination of the Opel-L (S) and the Talos-A (HA) Interbody systems will provide surgeons with a lower profile system and streamlined technique. It will help improve surgical efficiency while maintaining a robust anterior stabilisation.

It will also enable surgeons to accommodate individual patient anatomy.

Additionally, the new system has increased screw angulation and repeatable, more precise A/P alignment with an optional all-in-one drill guide during the placement of the device.

Meanwhile, Meditech is also rolling out hyper-lordotic sizes to its existing Talos-A (HA) line of osteoconductive PEEK-OPTIMA HA Enhanced ALIF implants.

With the existing CURE LP system and the FDA clearance of Opel-L (S), the company offers a comprehensive anterior lumbar system, providing surgeons with different options when treating complex anterior lumbar spinal procedures.

Meditech will donate a portion of proceeds from the sale of every plate to help CURE International to treat patients who are in need of surgical care.

The company expects to launch the integrated system in the third quarter of this year.

In 2017, the company received 510(k) clearance from FDA to market its Talos Lumbar (HA) Peek IBF lumbar fusion device.

Nasa’s Jet Propulsion Laboratory (JPL) has selected eight US manufacturers to make a new ventilator designed for Covid-19 patients.

The companies selected for licenses are Vacumed, Stark Industries, MVent, iButtonLink, Evo Design, DesignPlex Biomedical, ATRON Group and Pro-Dex.

Nasa noted that the companies have been selected from over 100 applications received by its laboratory.

Ventilator Intervention Technology Accessible Locally (VITAL), the prototype for the high-pressure ventilator, was developed by JPL engineers in 37 days with input from doctors and medical device manufacturers.

The design uses one-seventh the parts of a traditional ventilator and relies on parts already available in supply chains.

The ventilator design offers an affordable option for treating critical patients while freeing up traditional ventilators for those with severe Covid-19 symptoms.

The VITAL prototype received an emergency use authorisation (EUA) from the Food and Drug Administration (FDA) on 30 April.

The device has been successfully tested by the Human Simulation Lab in the Department of Anesthesiology, Perioperative and Pain Medicine at Mount Sinai in April.

The Caltech Office of Technology Transfer and Corporate Partnerships is offering a free licence for the device. Caltech, which owns the patents and software of VITAL, manages JPL for Nasa.

JPL is currently looking out for international manufacturers from countries such as Brazil, Mexico, India and Malaysia.

Meanwhile, a modified VITAL design was recently tested by Nasa at the UCLA Simulation Center in Los Angeles. The new design uses compressed air and can be launched at a wider range of hospitals.

The design has been submitted to the FDA for EUA and is currently under review.