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RAQA NEWS ROUND UP - (wc 06.05.19)

RAQA new medtech medical devices regulatory CE Mark Approved FDA

RAQA NEWS ROUND UP - (wc 06.05.19)

Levita Magnetic Surgical System Cleared by FDA for Prostatectomies

Levita Magnetics has received FDA approval to use its magnetic surgical system for prostatectomies. The device allows for minimally invasive surgery by reducing the number of ports required, as opposed to tradition open surgery and laparoscopic procedures.

The system works by delivering a grasping tool through an incision which then grasps the prostate. The shaft can then be removed to make room for another laparoscope or similar device. A magnet, placed externally at the treatment area, manoeuvres the prostate ready for removal reducing the number of shafts within the physicians view, as well as the number of incisions required.

“This newest indication marks significant progress for our technology that allows surgeons to offer prostatectomy with a new, less invasive alternative to patients,” said Alberto Rodriguez-Navarro, M.D., founder, president and CEO of Levita Magnetics. “Adding prostatectomy is another exciting milestone toward fulfilling our vision to minimize the footprint of surgery across multiple indications and broad patient populations with Magnetic Surgery, the next step in the evolution of minimally invasive surgery.”

The system is already in use for cholecystectomies (gall bladder removal) and bariatric surgeries.


CoapTech Gets FDA for PUMA-G Ultrasound System

CoapTech has been awarded FDA approval for its gastronomy device the PUMA-G Ultrasound System. Feeding tubes traditionally need to be placed via a hole in the abdominal wall, requiring the procedure to be undertaken in a surgical suite. The PUMA-G system however, allows feeding tubes to be placed at the patients beside, making it a safer and more cost effective alternative.

"As a healthcare provider, I have seen the challenges with current gastrostomy methods, and the delays in care and potential harm to patients that can result. The inspiration for this product came after seeing countless patients needing a simple G-tube insertion or replacement who needlessly wound up staying multiple days in the hospital waiting for a specialist and an operating room to be available," says CoapTech Founder and Chief Medical Officer Steven Tropello, M.D., a critical care and emergency medicine physician who invented the PUMA-G System. "Clinicians trained in point-of-care ultrasound will be able to utilize the PUMA-G System to safely and swiftly place a G-tube at the bedside, which should keep patients progressing on their journey towards recovery and home." 

The system is the first application of the company's PUMA system platform to received approval.

"Our hardworking team is honoured to have received FDA clearance as we continue our mission for safer, simpler, and faster patient care," says CoapTech CEO Howard Carolan.  "Based upon the success of the PUMA-G System to date, this milestone further motivates us to accelerate the development of other applications, expanding the PUMA platform to provide new solutions for ultrasound-guided procedures in other hollow organs of the body, such as the airway and lung."  


FDA Approves Vici Venous Stent System

has gained FDA approval for its Vici Venous Stent System for the treatment of iliofemoral venous obstructive disease. The disease, caused by conditions such as deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS) and compressive diseases such as May-Thurner syndrome, can result in venous obstruction, causing pain, swelling and skin ulcers.

Due to the location of the iliofemoral veins, they are subjected a high level of force from other anatomical structures, therefore, the device is made up of a network of tightly interlaced struts to support the high level of pressure placed on the vessels.

Boston Scientific Peripheral Interventions senior vice-president and president Jeff Mirviss said: “The FDA approval of the Vici venous stent system is the latest example of our commitment to building the most comprehensive portfolio of technologies specifically developed to meet the needs of physicians treating both chronic and acute venous disease.

“We are pleased to provide this differentiated stent system to US patients suffering from debilitating deep venous disease.”

The Vici stent, developed by Veniti, which was acquired by Boston Scientific last year, gained CE Mark approval in 2013.


Xcision Medical’s Breast Cancer Treatment Wins CE Mark

Xcision Medical has gained EU CE Mark approval for its GammaPod stereotactic radiotherapy system for the treatment of breast cancer.

The device delivers a higher and more targeted dose of radiation, resulting in fewer treatments for patients. It also allows patients receiving whole breast irradiation with a tumour bed boost could receive only one boost treatment rather than multiple.

The company hopes to start clinical trials later this year to investigate the benefits of receiving treatment from the GammaPod pre-surgery and in some cases, whether the treatment may eliminate the need for surgery completely.

“We are excited to bring GammaPod to the European market, where the need for more efficient, precise breast cancer radiotherapy treatments is increasing,” said Xcision founder and CEO Cedric Yu in a news release. “The ability of GammaPod to noninvasively deliver conformal radiation doses to only the affected area of the breast with the precision of stereotactic radiotherapy could certainly de-escalate care and reduce the burden of today’s protracted treatments on patients.”

The stereotactic radiotherapy system gained FDA clearance in 2017.

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