The Operating Theatre Journal - Journal - Page 40
NHS Ayrshire & Arran welcome Robotic-Assisted Surgery
We are delighted to announce the arrival of the first Robot-Assisted Surgery system to NHS Ayrshire & Arran.
The da Vinci robot-assisted surgery system is
the latest in modern surgical technology. The
robotic system is controlled by the surgeon
and enables them to perform very precise
and minimally invasive procedures in selected
patient cases. The system offers a number of
patient benefits compared with conventional
surgery such as, less blood loss, fewer
complications, less time in the hospital, less
chance of readmission to hospital and a faster
return to normal activities.
Mr Christopher Ray, a consultant in colorectal
surgery said: “We are excited to be following
in the footsteps of other Boards in Scotland
with this transformative technology.
“We want to ensure we are able to provide
the best patient experience we can for our
patients. Using this new technology we expect
patients to have better clinical outcomes.
Patients will be able to return to work and
other hobbies and activities sooner, with
the benefits that this brings to wellbeing
and society. With quicker recovery times and
shorter hospital stays we also expect robotassisted surgery to improve the hospital
efficiency and help increase our capacity to
allow us to see more patients.”
The new robot-assisted surgery system will be
based at University Hospital Crosshouse. Our
clinical teams in urology, gynaecology, and
colorectal surgery have already commenced
their training with the aim to start preselected patients later in the year.
Quote ‘OTJ’
Concept Medical’s fourth IDE approval for the MagicTouch Sirolimus Coated
Balloon is granted for the treatment of Superficial Femoral Artery Disease (SFA)
with atherosclerosis being the main cause. Stenosed and occluded SFA
remain major contributors to the PAD.
The IDE approval will allow Concept Medical to initiate pivotal clinical
study to demonstrate safety and effectiveness of the MagicTouch PTA
Sirolimus coated balloon in femoral and popliteal segments. The data
generated from this IDE clinical study will support a future pre-market
approval (PMA) application in the USA.
MagicTouch PTA is the world’s first Sirolimus coated balloon with
extensive commercial usage in Europe, major markets of Asia and the
Mid-Eastern markets. It is also the most clinically studied Sirolimus
Drug Coated Balloon (DCB) for PAD treatment, which includes the
largest head-to-head RCT against Paclitaxel DCB, and the largest RCT
against uncoated balloon.
The US FDA, on the 24th of May 2023, granted an Investigational
Device Exemption (IDE) approval for Concept Medical Inc’s Sirolimus
Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial
Femoral Arteries (SFA). This marks the fourth IDE approval for the
Company’s Sirolimus coated balloon.
The Company has already received three other pivotal IDE approvals
for its SCB MagicTouch family of products for the coronary InStent Restenosis (ISR), Coronary Small Vessel and Below-the-Knee
indications.
Concept Medical’s fourth IDE approval for the MagicTouch Sirolimus
Coated Balloon is granted for the treatment of Superficial Femoral
Artery Disease (SFA)
Lower extremity Peripheral Arterial Disease (PAD) affects an
estimated quarter million adults in Europe and North America and is
associated with significant morbidity and mortality,
40
Presently, the treatment options for PAD are limited to uncoated
PTA balloons, paclitaxel coated DCBs and a DES, thus restricting the
physician’s choice and alternatives for patients.
Uncoated balloons have been identified with substandard results post
intervention due to recurrent re-narrowing of arteries, and Paclitaxel
safety remains a debate due to association of the drug with longterm mortality. Sirolimus which has already proven safety in coronary
artery disease treatment, will fill this gap in PAD of safety and
efficacy in near future.
“We are extremely proud to have received the 4th IDE approval from
the USFDA for MagicTouch PTA in the SFA indication,” said Dr. Manish
Doshi, Founder and M.D. - Concept Medical Group.
“This milestone underscores our unwavering commitment to
advancing medical technology and providing innovative solutions that
have the potential to transform patient care.”
THE OPERATING THEATRE JOURNAL
SOURCE Concept Medical Inc.
www.otjonline.com