industry news

Boston Scientific has launched its WaveWriter Alpha line of Spinal Cord Stimulator (SCS) Systems in Europe.

The portfolio includes four MRI conditional and Bluetooth-enabled implantable pulse generators (IPGs).

They are designed to provide enhanced personalisation based on patient needs, including rechargeable and non-rechargeable options, and access to waveforms that can cover multiple areas of pain.

SCS therapies deliver pulses of mild electric current to the spinal cord and break off pain signals sent to the brain to provide pain relief.

The CE-marked WaveWriter Alpha SCS Systems support the management of chronic intractable pain. Additionally, they are approved for peripheral nerve stimulation of the trunk for pain management.

Chronic pain refers to continuous and long-term pain, lasting more than 12 weeks. It is estimated to affect nearly 100 million people across Europe.

Boston Scientific Neuromodulation senior vice-president and president Maulik Nanavaty said: “The launch of the WaveWriter Alpha SCS Systems in Europe represents a significant step forward in the treatment of chronic pain.

“By unifying our portfolio of SCS devices and offering the latest therapy advances, we remain committed to advancing meaningful innovation, providing both physicians and patients access to the full benefits of our entire portfolio of devices.”

The SCS systems feature combination therapy. It is the only SCS portfolio that can offer layer paraesthesia and paraesthesia-free options simultaneously, the company said.

Furthermore, these systems support up to 32 contacts that target specific nerves along the spinal cord to meet the personal pain relief coverage needs of the individual patient.

The COMBO randomised control trial, which assessed the effectiveness of SCS compared to conventional SCS, found that the system offers 50% or greater pain relief in patients with chronic pain.

Multiple Level 1 RCTs and real-world studies support the design of the SCS therapy, the company noted.

Last week, Boston Scientific announced the limited launch of the enhanced ACURATE neo2 aortic valve system in Europe.

GI Windows Medical has secured a breakthrough device designation from the Food and Drug Administration (FDA) for its self-forming magnetic compression anastomosis device.

The device is indicated for small bowel end-to-end anastomosis for ileostomy reversal or tissue resection.

The breakthrough devices programme is designed by the FDA to select medical devices that show potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

As part of the programme, the agency will enable priority review and interactive communication of GI Windows’ device development and clinical trial protocols during the premarket review process.

The magnetic anastomosis technology developed by the company offers a number of benefits for patients with colorectal disease.

In the US, colorectal complication rates are high due to anastomotic leaks, surgical site infections and bleeding, leading to high readmission rates and increasing the total cost to the healthcare system.

GI Windows’ anastomosis device is designed to help surgeons deliver less invasive solutions by using magnetic compression anastomosis. This enables clinicians to enhance patient outcomes and reduce healthcare costs.

GI Windows President and CEO Brian Tinkham said: “This designation is a major milestone for GI Windows as we aspire to change the paradigm in anastomosis creation throughout the GI tract.

“Our entire team has worked hard in developing the technology and evidence to achieve this designation from the FDA. We look forward to working collaboratively with the FDA to help prioritise development and access for patients.”

GI Windows is now sponsoring several studies to assess the safety, efficacy and durability of the magnetic anastomosis creation throughout the GI tract.

The company is a spin-off of Beacon Endoscopic, which was acquired by Covidien in 2014.

US medical technology company Surgical Innovation Associates (SIA) has secured CE Mark approval for its absorbable mesh, called DuraSorb.

The mesh offers mechanical support and scaffolding during the early months of wound healing and scar formation. It is gradually absorbed into the body in one year, leaving the patient free of foreign material.

The CE mark approval enables DuraSorb to be used for reconstructive and aesthetic purposes, including abdominal hernia prophylaxis, breast tissue support, and prosthetic breast support.

SIA noted that its technology adds great value in European hospital systems, as it offers a vital alternative to biologic meshes or permanent synthetic meshes.

Surgeons often try to avoid permanent mesh products, while human or animal-based biologic meshes are generally scarce due to safety concerns and high costs.

SIA president and CEO Dr Alexei Mlodinow said: “It is important that we expand access to our products for plastic and reconstructive surgeons and their patients beyond our own borders here in the US.

“We are excited to work with one of several potential partners across the pond to introduce DuraSorb in Europe and, in the future, other markets.”

SIA’s absorbable mesh has been designed by surgeons, textile experts and polymer scientists.

It received initial 510(k) clearance from the FDA for soft tissue support in 2018. Last year, the product was used clinically within a post-market registry.

The company began the US commercial efforts for DuraSorb earlier this year.

Currently, no mesh product has approval from the US FDA for any breast procedure.

Cardiac Dimensions has secured $17.5m in Series C financing round to accelerate the commercial sales of its Carillon Mitral Contour System in Europe.

The company will also use the funds to enter new markets such as Australia.

The latest round was joined by all existing shareholders of the company, including Aperture Venture Partners, Arboretum Ventures, Hostplus, Life Sciences Partners, Lumira Ventures, and M H Carnegie & Co.

Cardiac Dimensions develops minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure.

The company’s Carillon System is designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. It is developed to treat the major cause of FMR in patients with MR grades 2+, 3+ and 4+.

Earlier this month, Cardiac Dimensions received approval from Australia’s Therapeutic Goods Administration for the Carillon System for commercial use in FMR patients with mild to severe mitral regurgitation. The system was granted CE Mark in 2011.

Cardiac Dimensions CEO and president Rick Wypych said: “The Carillon System is a transformative product, which has shown great success in helping an extremely large patient population with very few options.

“The new round of financing will allow for continued growth of sales in Europe and provide capital for our expansion efforts into other geographies such as Australia. We thank our investors for their continued support as our business shows excellent results despite the challenging environment.”

It is estimated that 26 million people suffer from heart failure globally while nearly 70% of them have FMR.

H Carnegie & Co spokesperson Trevor Moody said: “We’re excited to support the expansion of sales of the Carillon System.

“Cardiac Dimensions’ innovative efforts and dedication to expanding access to the Carillon System will soon allow people worldwide to benefit from this therapeutic innovation.”

British medical technology company Smith+Nephew has agreed to acquire the Extremity Orthopaedics business of Integra LifeSciences in a deal valued at $240m.

The acquisition will boost the extremity business of Smith+Nephew. It forms part of the company’s strategy to invest in higher-growth segments.

The company noted that the deal will provide it with a focused sales channel, complementary shoulder replacement and upper and lower extremities portfolio, as well as a range of new offerings, including devices, implants and instruments.

The acquired business’s focused extremities commercial channel includes a specialised sales force and distributors in Canada, Europe and the US.

Smith+Nephew noted that the product portfolio of Extremity Orthopedics is highly complementary to its current orthopaedics offering. It will enable the company to expand its presence in shoulder replacement and foot and ankle segments sector.

Furthermore, the Extremity Orthopaedics R&D pipeline includes a next-generation shoulder replacement system, which is scheduled for commercial launch in 2022.

Smith+Nephew Global Orthopaedics president Skip Kiil said: “Integra’s Extremity Orthopaedics business is an established global player in the rapidly growing extremities segment, including total shoulder replacement, and has a well-regarded specialised sales channel and a strong pipeline of new products.

“This strategic acquisition represents a significant opportunity to strengthen Smith+Nephew’s position in a high-value area and allows us to offer a leading extremities portfolio to customers.”

Extremity Orthopedics operates facilities in Austin, Texas, US, and Lyon, France. Following the acquisition, approximately 300 employees are expected to join Smith+Nephew.

Integra LifeSciences Extremity Orthopaedics senior vice-president Peter Ligotti added: “We are looking forward to joining an organisation that is committed to growing and expanding its orthopaedic product portfolio. We are excited for the opportunities ahead as we continue to advance orthopaedic innovations for our customers and improve patient outcomes.”

The transaction, subject to customary conditions and consultation with employee representative bodies, is expected to close by the end of this year.

Smith+Nephew plans to finance the deal, using its existing cash and debt facilities.

Last year, the company acquired Swiss optical tracking technology maker Atracsys Sarl to support its digital surgery system.

Boston Scientific has announced the limited launch of the enhanced ACURATE neo2 aortic valve system in Europe.

The new system uses transcatheter aortic valve implantation (TAVI) technology. It builds on the clinical performance of the original ACURATE neo platform.

Designed to restore function and normal blood flow through a severely narrowed aortic valve, the new valve system features annular sealing technology. It helps the device to conform to irregular, calcified anatomies and further reduce paravalvular regurgitation or leaking (PVL).

Moreover, the delivery system simplifies access to smaller and complex vessels at the entry site and enables highly accurate valve positioning.

Its top-down deployment mechanism enhances stable placement and release, ensuring better patient outcomes.

The ACURATE neo2 aortic valve system has an expanded indication for patients with aortic stenosis.

Patients who are considered suitable candidates for the therapy by their heart team, including a cardiac surgeon, can undergo the treatment using this, despite their age and risk level, the company noted.

Boston Scientific Interventional Cardiology president Joe Fitzgerald said: “We believe having this differentiated valve with the enhanced sealing technology will further drive favorable market experience and growth.

“Combined with the LOTUS edge aortic valve system and SENTINEL cerebral protection system to protect the brain against the risk of TAVI-related stroke, the ACURATE neo2 valve represents the natural evolution of our complementary dual-valve TAVI toolkit that covers the needs of a wide range of patient cases.”

The ACURATE neo2 CE-Mark study found that PVL rates for the ACURATE neo2 valve system is lower compared to that of current generation ACURATE neo valve.

Boston Scientific executive vice-president and global chief medical officer Dr Ian Meredith said: “We are pleased to bring the latest iteration of ACURATE technology to market, offering design improvements that further support procedural performance and optimal outcomes for patients with severe symptomatic aortic stenosis from those with simple to the most challenging anatomies.

“The straightforward implant procedure also enables physicians to reduce the length of time patients need to stay in the hospital without compromising on safety and clinical results.”

The ACURATE neo2 Aortic Valve System received CE Mark in April. The system is currently under ACURATE IDE clinical trial in the US and is not available for sale.

Last week, Boston Scientific signed an investment agreement with privately held medical device company Farapulse with an exclusive option for acquisition.