Genesis MedTech Announces FDA Breakthrough Device Designation for the J-Valve™ Transfemoral System

Genesis MedTech, a leading medical device company, announced that the US Food and Drug Administration (FDA) has designated its J-ValveTM Transfemoral (TF) System as a Breakthrough Device. This innovative heart valve has received Breakthrough Device designation for the proposed indication of treating severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients deemed eligible for the device and at high risk for open surgical aortic valve replacement by a heart team.

This revolutionary technology is intended for patients suffering from aortic valvular disease. A common problem that can lead to heart failure is aortic regurgitation. The J-Valve transcatheter aortic valve replacement treatment uses a minimally invasive transvascular approach, eliminating the need for open-heart surgery or extracorporeal circulation. To attach the device to a failing valve, the method employs an anchor mechanism and a stent frame that swells. The J-Valve TF system, by assisting in the restoration of normal blood flow out of the heart and into the body, has the potential to minimise and/or alleviate symptoms of heart failure such as breathing difficulties, chest pain, and fatigue.

The recognition of the J-Valve TF System as a Breakthrough Device highlights the significance of this revolutionary development for cardiovascular patients. JC Medical will get prioritised review and interactive communication with the FDA as part of the programme throughout the premarket review phase. A device must indicate a reasonable expectation that it could provide more effective treatment or diagnostic of the disease or condition identified in the proposed indications for use in order to be designated as a Breakthrough Device.

“We are hopeful that these designations will aid in providing timely treatment for a condition for which no transcatheter valves are currently approved in the United States.” Dr. Mark A. Turco, CEO JC Medical and President of Vascular Intervention North America at Genesis MedTech, remarked, “We look forward to continuing our work with the FDA to bring this life-saving technology to patients in need.”

STARmed Co., Ltd Expands its Reach with the Launch of STARmed America in the USA

STARmed Co., Ltd, a renowned medical device company specialising in thermal ablation technology, announced the establishment of STARmed America in the United States. This strategic change intends to improve direct customer service while also encouraging collaboration with the US market for cutting-edge thermal ablation technologies. STARmed America will be an important centre for innovation and collaboration.

STARmed Co., Ltd has emerged as a young and rapidly expanding company committed to revolutionising thermal ablation technology. The company specialises in radiofrequency ablation generators and electrodes, and has built a solid reputation both in the United States and abroad. Working closely with Key Opinion Leaders (KOL) in the medical area has been a main focus for STARmed, which has resulted in the development of cutting-edge radiofrequency (RF) technology for a variety of therapeutic applications. STARmed America will strengthen its commitment to driving medical innovations through strategic partnerships by cultivating an even more innovative culture.

“The mission of STARmed is to maintain the highest levels of innovation, knowledge, and technical expertise in order to provide solutions that enhance patient comfort and improve the quality of their lives,” said Henry Shin, CEO of STARmed Co., Ltd. “With the launch of STARmed America, we are poised to deliver on this mission by working closely with our USA customers and leveraging potential opportunities to advance thermal ablation technology even further.”

STARmed has become a globally recognised and respected name in the business, with a phenomenal presence in over 79 countries worldwide. While STARmed’s initial focus was on Liver RFA, the company has made tremendous progress in the development of RF technologies for Thyroid RFA. STARmed has emerged as the global leader in Thyroid RFA in less than 8 years, with over 70% of clinical studies using STARmed devices. The remarkable clinical results and minimal complication rates linked with the company’s products indicate the technology’s efficiency and dependability.

icotec ag Announced FDA 510(k) Clearance for VADER® Pedicle System Navigated Instruments, Advancing Precision and Safety in Spinal Implantation

On July 27, 2023, icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, announced the FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. The approval represented a significant step forward in enhancing surgical precision and safety for spine surgeons using our innovative BlackArmor® Carbon/PEEK implants.

A wide variety of instruments for both open surgery and minimally invasive surgery are included in the recently cleared Navigation set. By giving surgeons more precision and accuracy during procedures, this expanded portfolio equips them to produce better results for their patients.

As part of their commitment to providing the safest and most seamless surgical experience, icotec integrated assistive technologies, such as navigation, into their instrumentation. The combination of standard surgical techniques with advanced navigation capabilities ensures that their procedures align with industry standards and deliver optimal outcomes for patients globally.

“Receiving FDA 510(k) clearance for our navigated instrumentation is a significant achievement for icotec,” said Roger Stadler, CEO at icotec, “We are proud to offer our surgeons the tools they need to perform these procedures with the utmost precision and confidence. This clearance opens new opportunities for growth and reaffirms our position as the leader in Carbon/PEEK implants and our commitment to keeping a standard surgical technique.”

According to DelveInsight’s “Spinal Surgery Devices Market” report, the global spinal surgery devices market is estimated to grow at a CAGR of 5.65% during the forecast period from 2023 to 2028. The spinal surgery devices market is observing remarkable market growth owing to various factors such as the subsequent rise in spinal disorders across the globe, increasing road accidents, and increasing demand for minimally invasive surgical procedures among others. Further, the increasing demand for technologically advanced spinal surgery devices in the market will also spur market growth in the forthcoming years. Additionally, a rise in spending on spinal surgery products along with the increasing product launches and approvals, and other factors will create a requisite for the spinal surgery devices in the market. Therefore, the market for spinal surgery devices is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

Terumo BCT’ Reveos® Automated Whole Blood Processing System Cleared by FDA for US Commercial Use

On Aug. 1, 2023, Terumo Blood and Cell Technologies (Terumo BCT) announces U.S. Food and Drug Administration (FDA) clearance of the Reveos Automated Whole Blood Processing System, the first whole blood automation device available in the US that processes whole blood into platelets and other components in a single centrifugation cycle. The Reveos system, the only device of its kind in the world, will improve the blood and platelet supply for patients in the United States through automated whole-blood processing. 

It intends to assist American blood centers in boosting the supply of platelets, cutting labor expenses, and raising overall operational effectiveness. The amount of time that laboratory workers must work can be cut in half or even more with Reveos’ automated whole blood processing. In the past, manual techniques that require up to 18 or 20 steps have been used to separate the components of whole blood after it has been collected from donors. Reveos streamlines this procedure and gets rid of more than half the processes.

“Reveos has a long-standing track record for helping blood centers globally meet the critical needs of patients while creating efficiencies in their operations,” said Antoinette Gawin, President and CEO of Terumo BCT. “We continue to invest significantly in innovation for the future and in supporting blood centers. Reveos and IMUGARD together target the growing and critical need for platelets. These are just more examples of our holistic work supporting blood centers.”

“Reveos will help blood centers maximize the use of whole blood donations while increasing the availability of platelets for patients in need,” said Bill Block, President and CEO of Blood Centers of America, the largest blood supply network in the U.S. “We look forward to deploying this technology within our membership and at our blood center partners across the country later this year.”

Patients with a variety of illnesses, including cancer and trauma, are treated using platelets. Currently, apheresis—a procedure that involves drawing a donor’s blood, separating the necessary components from it, and giving the remaining blood back to the donor—provides 94% of the platelets that are available for transfusion in the United States. It is anticipated that platelet usage will rise faster than apheresis donations. Following FDA approval, automated Reveos systems may now efficiently extract platelets from existing whole blood donations at blood centers.

Terumo BCT continues making investments to support blood centers. The FDA approved the IMUGARD WB Platelet Pooling Set in 2022, supporting an increase in platelet shelf life from five to seven days. The IMUGARD WB Platelet Pooling Set, which contains platelets produced by Reveos and may be pooled on either day one or day two following collection, was given an intended use statement as part of the Reveos approval by Terumo BCT. This gives blood centers utilizing Reveos even more flexibility.

As per DelveInsights’, “Blood Collection Devices Marketreport, the blood collection devices market was valued at USD 6.23 billion in 2021, growing at a CAGR of 6.85% during the forecast period from 2023 to 2028 to reach USD 9.25 billion by 2028. Increased diagnostic testing due to the rising incidence of infectious diseases, and others, rising health awareness, an increase in blood transfusion procedures, and a growing emphasis on enhancing the safety and usability of blood collection devices for end users are expected to contribute to the blood collection devices market in the upcoming years.