Smith+Nephew Launched Hip Arthroplasty System in India 

On August 17, 2023, The London-based orthopedic device maker Smith+Nephew announced the launch of its OR3O dual mobility system for use in primary and revision hip arthroplasty in India.

The dual mobility implants have a smaller-diameter femoral head than standard options. It latches into a bigger polyethylene insert, boosting stability, lowering the chance of dislocation, and expanding range.

The bearing surface of the OR3O system utilizes Smith+Nephew’s advanced Oxinium DH for its liner and proprietary Oxinium on XLPE for its femoral head and polyethylene inserts which makes it different from other hip implants that utilize a cobalt chrome (CoCr) liner with CoCr/SST or ceramic head balls. 

This also eradicates the modular CoCr liner and/or CoCr head ball from the construct. The risk for wear and corrosion associated with the alloy is also lower with the OR3O system. The system also offers cross-compatibility with the R3 Acetabular system. 

The product was initially launched in the US in 2020.

Joaquin Lasso, managing director, of South Asia, Smith+Nephew said, “Smith+Nephew’s OR3O dual mobility system is a groundbreaking introduction for India that offers technology not available in other systems.” Lasso added, “Over a dozen peer-reviewed publications have now cited or expressed concerns over corrosion or elevated ions in CoCr modular dual mobility liners. The reduced corrosion of our Oxinium and Oxinium DH bearing surface sets OR3O apart from the competition.”

 As per DelveInsight’s Hip Reconstruction/Replacement Devices Market” report, the hip reconstruction/replacement devices market was valued at USD 9.26 billion in 2022, growing at a CAGR of 5.06% during the forecast period from 2023 to 2028 to reach USD 12.44 billion by 2028. The rise in demand for hip reconstruction/ replacement devices is primarily due to the rising geriatric population across the globe, the increase in obesity owing to a sedentary lifestyle, the introduction of custom-made implants, and technological advancement in the product portfolio, among others.

Mammotome Launched the HydroMARK™ Plus Breast Biopsy Site Marker, an Innovation for Tissue Marker Displacement 

On August 21, 2023, Mammotome, to enhance ultrasound visibility, improve ease of locating, and mitigate displacement during surgical procedures announced the launch of an innovative new HydroMARK™ Plus Breast Biopsy Site Marker.

This device marks another great investment to the HydroMARK™ tissue marker portfolio, one of the top-selling breast biopsy marker brands in the world. The HydroMARK™ Plus marker has the same unmatched benefits as the original HydroMARK™ marker portfolio featuring exclusive hydrogel technology. 

The HydroMARKTM Plus marker provides the same unparalleled benefits as the original HydroMARKTM marker range, which includes proprietary hydrogel technology. The hydrogel-based carrier hydrates more than 200% of its original size within 24 hours and becomes dramatically anechoic within 12 months, allowing for long-term ultrasonography visibility even in patients receiving Neoadjuvant Chemotherapy (NACT). 

When paired with the HydroMARKTM Plus form, which extends beyond the carrier, this feature is intended to improve visibility and ease of location under ultrasound compared to the original HydroMARKTM markers. The one-of-a-kind “dragonfly” marker shape includes “wings,” which are meant to anchor to the tissue and reduce displacement from the biopsy site during surgical excision, assisting surgeons in accomplishing their procedural goals.

By the end of 2023, HydroMARK™ Plus Breast Biopsy Site Marker will be available to clinicians in the United States. The company has plans to expand to Canada and other select countries across the globe.

“I am excited for this innovative biopsy marker to come to market, “commented Radiologist Dr. Evita Singh, Director of Breast Imaging at Karmanos Cancer Institute. Evita further mentioned, “After seeing the tabletop test on the HydroMARK™ Plus Breast Biopsy Site Marker, I look forward to having a solution that addresses the need for a nickel-free, long-term, ultrasound visible clip that will not displace for the surgeons.” 

Sarah Moore, President of Mammotome said, “With patients at the center of everything we do, we are proud to bring an innovative product to clinicians that advances breast care.” Sarah Moore commented, “We expect the HydroMARK™ Plus marker to significantly improve visibility at placement and add surgical efficiency, which will benefit radiologists, surgeons, and the patients they serve.”

According to DelveInsight’s “Breast Biopsy Market” report, the global breast biopsy market is estimated to grow at a CAGR of 5.5% during the forecast period from 2023 to 2028. The main factors driving the growth of the global breast biopsy market are an increase in the incidence of breast cancer coupled with the expansion of breast cancer screening programs as well as the surgical acceptance of minimally invasive breast biopsies. The market is expanding as a result of technical improvements and advancements in breast biopsy instruments among others during the forecast period. 

Levita® Magnetics Gained the US FDA Clearance for Pioneering MARS™ System

On August 22, 2023, Levita Magnetics, whose mission is to help more patients get access to better surgery, announced the US Food and Drug Administration (FDA) clearance for its MARS™ platform which is a first-of-its-kind minimally invasive surgical platform for the high-volume abdominal surgery market.

MARS™ platform harnesses the power of both magnets and machines and enables surgeons to have complete control during laparoscopic procedures and also lessens the number of incisions required during the procedure. 

Built on the success of its first commercial product, the Levita Magnetic Surgical System, MARS is meant to deliver the same benefits with triple impact: 

  • The benefit of less-invasive surgery with reduced incisions, results in less pain, faster recovery, and fewer scars for patients. 
  • The advantage of full control over both the laparoscopic view, reduced need for an additional assistant – as well as over the magnetic surgical system, and the ability to retract large tissues and organs such as the liver, gallbladder, prostate, and colon for surgeons.  
  • The benefit of increased efficiency, more effective deployment of OR personnel, and the ability to offer a differentiated patient experience to Hospitals and Ambulatory Surgical Centers (ASCs). 

“Today marks a significant milestone in Levita’s mission to provide more patients access to state-of-the-art surgical technology. MARS is poised to revolutionize surgical options for a broad range of patients,” said Dr. Alberto Rodriguez-Navarro, surgeon, founder, and CEO of Levita Magnetics. Dr. Alberto added, “With this FDA clearance, we eagerly anticipate making a substantial impact across the value chain.” 

Maria Sainz, Levita Chairperson said, “MARS by Levita has the potential to reshape the surgical industry and forever change medical innovation. Our pioneering MARS platform gives patients and surgeons a transformative tool that will usher in a fundamental shift in surgery for years to come.” Maria also mentioned, “Levita’s system can aid in surgeon proficiency and efficiency, and can reduce the need for assistive personnel, signaling a major achievement not only for Levita but for surgical care.” 

According to DelveInsight’s “Minimally Invasive Surgical (MIS) Devices Market” report”, the global minimally invasive surgical (MIS) devices market valued at USD 28,873.25 million in 2022, growing at a CAGR of 7.38% during the forecast period from 2023 to 2028, to reach USD 42,499 million by 2028. The MIS devices market is witnessing positive market growth owing to the factors such as the rising prevalence of various cancers such as lung cancer, and other indications such as cardiovascular diseases, and neurodegenerative diseases among others. Furthermore, the presence of factors such as growth in the aging population wherein age plays a key role in the development of various indications is another factor driving the growth of the MIS devices market. Moreover, the technological advancements in product development such as the development of surgical robots are further driving the MIS devices market as new products are gaining regulatory approvals and are entering the market.

Geneseeq Gained CE Marks for NGS-based Test Kits for Solid Tumors and Hematological Cancer

On August 22, 2023, Geneseeq Technology Inc. announced that three of its next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus DNA/Hemarna RNA), obtained the European Union’s CE Mark approval. 

The GeneseeqPrime and GeneseeqPrime HRD are cleared for solid tumor genomic profiling, while Hemasalus DNA/Hemarna™ RNA is cleared for hematological cancer genomic profiling. 

The company currently offers five CE-marked cancer genetic testing kits tailored for various clinical situations. 

The GeneseeqPrime kit employs 437 genes linked to solid tumors, and the reportable range includes single nucleotide variants (SNVs), insertions and deletions (indels), copy number variants (CNVs), gene translocations and large genomic rearrangements (LGR), tumor mutational burden (TMB), microsatellite instability (MSI), and DNA mismatch repair (MMR) genes. 

This test gives clinically important information that can be used to inform and guide therapy decisions. It provides critical insights into key oncogenic genes and potential drug resistance pathways. 

Aside from the data provided by GeneseeqPrime, the GeneseeqPrime HRD report includes the homologous recombination deficiency (HRD) status, which can be used for PARP inhibitor treatment recommendations. The Hemasalus DNA/Hemarna RNA probe looks for genetic variants and translocations in 475 genes on the DNA level, as well as translocations in 232 genes on the RNA level. 

This kit supports clinical diagnosis and therapy planning for people suffering from hematological malignancies.

“The CE Mark validation for the GeneseeqPrime™, GeneseeqPrime™ HRD, and Hemasalus™ DNA/Hemarna™ RNA kits underscores our dedication’s commitment to high-quality testing standards on a global level,” said Dr. Xue Wu, CEO of Geneseeq Canada. Dr. Wu added, “The Geneseeq cancer genetic testing kit encompasses a comprehensive assay kit for sequencing, an automated reporting system, and a seamless end-to-end service that covers assay setup and customer support. These kits will now be accessible to healthcare professionals in Europe, enabling them to formulate treatment plans for individuals affected by cancer.” 

According to DelveInsight’s “Blood Cancer Diagnostics Market” report, the global blood cancer diagnostics market is estimated to grow at a CAGR of 6.34% during the forecast period from 2023 to 2028. The blood cancer diagnostics market is slated to witness prosperity owing to factors such as the growing prevalence of blood cancer worldwide, the increasing geriatric population, the rising number of risk factors associated with blood cancer, the growing focus on improving the safety, and usability of blood cancer diagnostics for end users are further expected to result in the appreciable revenue growth in the blood cancer diagnostics market during the forecast period (2023-2028).

First Patient Enrolled in Non-Pharmacologic Hypertension and Heart Failure Treatment Trial of BaroPace, Inc.

On August 22, 2023, BaroPace Inc., a medical device company focused on the development of PressurePace™, a real-time physiologic control software, and hardware to regulate cardiac pacemakers to treat resistant hypertension and heart failure with preserved ejection fraction (HFpEF), announced the enrolment of the first patient in the Company’s First-in-Human (FIH) clinical trial, RelieveHFpEF-II. 

A multicenter, double-blind RelieveHFpEF-II trial aims to evaluate the safety and effectiveness of PressurePace™, the Company’s proprietary real-time closed-loop pacemaker control algorithm that, for the first time, regulates a cardiac pacemaker according to blood pressure in patients with HFpEF.

The study being conducted in India involving sixteen subjects with HFpEF caused by hypertension will compare standard pacemaker therapy, including rate adaptive pacing via pacemaker accelerometer, with PressurePace™.

After one week of baseline measurements, patients who have stable blood pressure and body weight are randomized to three weeks of normal pacemaker therapy versus PressurePace. Pacemaker programming changes are performed twice daily at the patient’s home in the treatment group (BaroPacing), whereas sham programming is performed in the control group (placebo). 

The safety, improved exercise performance (modified BRUCE treadmill protocol and six-minute walk test), and the Minnesota Living with Heart Failure Questionnaire are the primary endpoints of the trial. Secondary endpoints include blood pressure control (systolic and diastolic blood pressure and 24-hour blood pressure monitoring), atrial fibrillation incidences, and hospitalization frequency.

Michael Burnam MD, BaroPace’s Co-founder and CEO stated, “We’re pleased to initiate this First-in-Human trial of PressurePace™.” Michael added, “This milestone highlights our commitment to developing new, innovative non-pharmacologic technology that improves the quality of life and longevity of patients worldwide with resistant hypertension and HFpEF, two of the most important unmet needs in cardiovascular medicine. We look forward to continued enrollment of subjects in RelieveHFpEF-II.” 

According to DelveInsight’s “Pacemakers Market” report, the global pacemakers market was valued at USD 4.88 billion in 2022, growing at a CAGR of 5.85% during the forecast period from 2023 to 2028, to reach USD 6.84 billion by 2028. The demand for pacemakers is primarily motivated due to the rise in cardiovascular diseases (CVDs), superior treatment outcomes of sudden cardiac arrests, and growing technological advancements among others during the forecast period.

Quanta™ Completed Enrollment in Home Run Study

On August 17, 2023, Quanta Dialysis Technologies announced the completion of enrollment of its Home Run study for at-home hemodialysis. 

A prospective, multicenter, open-label Home Run study aims to assess the efficacy and safety of the Quanta Dialysis System for home hemodialysis. 

Following enrollment, using the Quanta Dialysis System participants will begin hemodialysis treatments on a prescription of four-hour treatments, three times per week for a minimum of four weeks. 

Both the patients and their caregivers will undergo extensive training and competency sign-off on all aspects of safely administering hemodialysis treatment in the home during this time. The participants will perform home treatment four times per week for three-and-one-half hours per treatment for eight weeks upon completion of training and a one-week transition period. 

A compact, easy-to-use hemodialysis device, Quanta Dialysis System has already gained US FDA clearance for its utilization in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. The device is also CE-marked for use in the center or at home in the UK by adult patients with AV fistula or graft or central venous catheter, and who have an estimated dry weight of greater than 40kg.

The results of the home run study are expected to be announced in the second half of 2023. 

“People with end-stage kidney disease on hemodialysis are currently limited as to options available. Although frequent home hemodialysis is proven to deliver superior outcomes, for many, in-center dialysis treatment three times a week is the only viable option,” said Quanta Chief Medical Officer, Dr. Paul Komenda, MHA, FRCPC, and FASN. Dr. Paul added, “We hope that FDA clearance of an additional home hemodialysis device will contribute to more patients having access to regular care in their home environment. Enrollment completion is the first step forward in a potential new alternative for people with this life-threatening disease.” 

According to DelveInsight’s “Hemodialysis Machines Market” report, the global hemodialysis machines market was valued at USD 13.53 billion in 2022, growing at a CAGR of 4.71% during the forecast period from 2023 to 2028 to reach USD 17.78 billion by 2028. The increase in demand for hemodialysis machines is primarily attributed to the increasing prevalence of kidney disorders such as end-stage kidney disorder, kidney failure, and others. In addition constantly increasing old population, high blood pressure, and high diabetes prevalence is also driving factor for hemodialysis machines as old age and diabetic people are more likely to develop kidney disorders. Moreover, technological advancement in the hemodialysis machines product pipeline and an increase in product approvals are among the other factors responsible for the growth of the global hemodialysis machines market during the forecast period from 2023 to 2028.