5 medtech stories we missed this week: July 6, 2018

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From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning.

1. Zetta wins FDA clearance for Zoom MRI software

Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known as Zoom, features an algorithm for image quality enhancement and image optimization of short scanning techniques. It works with all MRI models from all major manufacturers, according to the company. Zoom’s algorithm was designed to help MRI imaging departments automatically process MRI imaging techniques.

2. MIM Software, Spectrum Dynamics Medical ink software deal for Veriton scanner

MIM Software and Spectrum Dynamics Medical have partnered to provide MIM-SD advanced visualization and quantitative processing software for the Veriton, according to a June 24 press release. Veriton is a 12 detector CZT multi-organ scanner that has unparalleled sensitivity, image quality and diagnostic accuracy. The detectors are configured for each organ and offers high resolution, lower dose and shorter acquisition times.

3. LumiThera wins CE Mark for LT-300 device for macular degeneration

LumiThera announced in a June 21 press release that it has received CE Mark for its LT-300 device that treats dry advanced macular degeneration. The device is a light delivery system. The CE Mark approval allows the company to commercialize the device in Europe.

4. RTI Surgical launches Fortilink IBF systems

RTI Surgical has launched its Fortilink-TS and -L IBF Systems, according to a June 12 press release. The systems are designed to be used in lumbar interbody fusion procedures at one or two adjoining levels in patients who have degenerative disc disease. Both systems feature the company’s TetraFuse 3D technology that is a 3D printed polymer-based interbody fusion device that uses a nano-rough surface to create more notable trabecular bone ingrowth.

5. Prescient Medical wins CE Mark for CleanCision

Prescient Surgical announced in a June 12 press release that it has received CE Mark approval for its CleanCision system. CleanCision fights and defends against surgical site infection sources. The approval allows for the commercialization of the system throughout Europe. In addition to the CE Mark approval, Prescient Surgical also received ISO 134385:2016 certification for its quality management system.

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Intuitive Surgical wins FDA nod for 60mm stapler

Intuitive Surgical (NSDQ:ISRG) said today that the FDA cleared its fully-wristed 60 mm stapler, SureForm 60.

The device is a single-patient-use stapler featuring 120 degrees of fully-wristed articulation, which Intuitive touts as “an industry first.”

Beyond the 60 mm device, Intuitive’s stapling portfolio includes 30 and 45 mm stapler instruments.

The stapler uses Intuitive’s SmartFire software to measure tissue compression before and during staple firing, automatically adjusting to the firing process as staples are formed, the company explained.

Surgeons control Intuitive’s latest stapler via the daVinci console – it’s compatible with the da Vinci Xi and X systems. The SureForm 60 device has general, thoracic, gynecologic, urologic and pediatric indications, according to Intuitive.

“Intuitive continues our minimally invasive innovation with our 60mm stapler, rooted in extensive research and development and an understanding of surgeons’ needs,” Sal Brogna, EVP & COO, said in prepared remarks.

ISRG shares were trading at $487.39 apiece in late afternoon activity today, up +0.4%.

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Arthrosurface nabs 510(k) clearance for patellofemoral WaveKahuna arthroplasty system

Arthrosurface said last month that it won 510(k) clearance from the FDA for its patellofemoral WaveKahuna arthroplasty system.

The Franklin, Mass.-based company’s PF WaveKahuna device is designed to restore the articular surface geometry of the patella and femoral trochlea. The system tackles the challenging PF tracking and stability conditions and gives increased coverage of the trochlear groove, according to Arthrosurface.

The company also noted that the device’s design combines the clinical benefits of the anatomic and dome patella implants from the PF Wave system. The PF WaveKahuna femoral component can match up with the company’s PF Wave Fixation component, Arthrosurface added.

“As a market leader in patellofemoral arthroplasty, we are very excited to round out our line with the PF WaveKahuna System. The larger implants will allow a surgeon to choose from a wide range of size offerings to better serve the patient’s needs and allow them to maintain their quality of life,” Shane Shankle, VP of U.S. sales, said in prepared remarks.

“The FDA clearance comes shortly after data recently presented at ESSKA confirmed significantly improved postoperative outcomes with high patient satisfaction and no progression of knee arthritis at 5 years follow-up. The timing could not be better,” Dawn Wilson, VP of quality & regulatory, added.

In April, Arthrosurface won FDA 510(k) clearance for its OVOMotion shoulder arthroplasty system.

The company explained that its newly-cleared stemless total shoulder system is designed to minimize bone removal specifically for patients with painful or severely disabled shoulder joints from arthritis, traumatic events or avascular necrosis.

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FDA approves ReCor Medical’s pivotal ultrasound denervation study

ReCor Medical said this week that the FDA approved a new pivotal study of the company’s Paradise ultrasound denervation system for the treatment of hypertension.

The Palo Alto, Calif.-based company reported that its trial, Radiance-II, will be a randomized, sham-controlled study in patients with moderate hypertension. The study is designed to demonstrate the Paradise system’s safety and ability to lower blood pressure.

ReCor plans to start enrolling patients for Radiance-II in October.

“We have had a very constructive dialog with the FDA during the past 9 months to craft what we believe is a strong study to develop a robust set of clinical data to support the future FDA review for PMA approval,” Leslie Coleman, VP of regulatory & medical affairs, said in prepared remarks. “At the time of PMA submission we plan to have 4 independently-powered, blinded, sham-controlled, randomized studies of the Paradise System in patients with different stages  of hypertension – our Solo, Trio, Require, and Radiance-II studies – approaching a total of nearly 500 subjects, with outcomes as long as 3 years.”

“Our steering committee and medical advisors have been instrumental in the design of the global Radiance clinical program – including the Radiance-II pivotal study – for the US, EuropeJapan and Korea,” Helen Reeve-Stoffer, VP of clinical affairs, added. “Given the recent positive Solo results, and subsequently the numerous review articles in medical journals, we recognize the potential impact the Paradise System may have in the treatment of hypertension for millions of patients world-wide. Accordingly, ReCor is committed to conduct rigorous, randomized, controlled studies to demonstrate the safety and efficacy of the Paradise system to lower blood pressure, thus helping physicians to evaluate how, in whom, and when to use Paradise for the treatment of hypertension.”

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Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat

Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat.

The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and patients.

“This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e’s 21st Century First Aid Kit. We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery,” chief scientific officer Dr. Matthew Dowling said in a press release.

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Pulmonx wins FDA approval for Zephyr endobronchial valve

The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema.

Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The Zephyr device is designed to decrease the volume of the chest to improve function in the heart, respiratory muscles and healthy lung tissue. Inserted via bronchoscopy, the pencil-eraser-sized valves prevent air from entering the diseased alveoli but allow it to escape during exhalation.

The federal safety watchdog said it granted Zephyr’s PMA based on a 190-patient study comparing treatment with Zephyr, plus standard medical management and pulmonary rehabilitation, to treatment with standard medical management and rehab only. The trial’s benchmark was at least a 15% improvement in pulmonary function score.

Some 47.7% of patients in the Zephyr arm met that mark, compared with 16.8% of the control arm, according to the FDA. Adverse events included death, pneumothorax, pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain, the agency said.

“Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These have included lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients,” Tina Kiang, acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control & Dental Devices, said in prepared remarks. “This novel device is a less invasive treatment that expands the options available to patients.”

Pulmonx said more than 14,000 patients have been treated with the Zephyr valve worldwide since 2007.

“It is gratifying to be able to tell the many US patients who have contacted us that help is on the way. We thank FDA for its swift review of the Zephyr Valve. By combining the Zephyr Valves and our patient selection tools, we are bringing precision medicine to the treatment of severe emphysema,” added Pulmonx CEO Glen French.

“Zephyr valves are a major step forward in treating severe emphysema patients who consistently feel short of breath despite all the medications we can offer. I have seen Zephyr valve-treated patients getting back to a more active life doing the things they enjoy. As a physician, it is very gratifying to have a new treatment that can restore a patient’s confidence and change their life for the long term,” lead investigator Dr. Gerard Criner, of Temple University’s Lewis Katz School of Medicine, said in a press release.

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Ocular Therapeutix resubmits NDA for ocular pain relief implant

Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a new drug application for its Dextenza ocular pain relief implant to the FDA.

The Bedford, Mass.-based company noted that the resubmitted application aims to address manufacturing deficiencies highlighted by the FDA last year when the agency rejected Dextenza for the second time.

Get the full story at our sister site, Drug Delivery Business News.

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Apollo Endosurgery wins expanded FDA nod for OverStitch Sx system

Apollo Endosurgery said today it won special FDA 510(k) clearance for its OverStitch Sx endoscopic suturing system, an accessory for its already cleared OverStitch Sx system intended to simplify attachment of the device to compatible endoscopes.

The Austin, Texas-based company said that the special clearance is the last regulatory nod it needed before it could introduce the system into the US market.

The newly cleared accessory makes the system, which was previously limited in compatibility to a select number of dual-channel endoscopes, compatible with a wider range of endoscopes, Apollo said in a press release.

Earlier this month, Apollo Endosurgery said it closed a $23.7 million round of financing.

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Renovis wins FDA nod for Tesera ALIF interbody spinal fusion system

Renovis Surgical Technologies said today that it won 510(k) clearance from the FDA for its Tesera SA hyperlordotic ALIF interbody spinal fusion system.

The company’s porous, titanium, stand-alone anterior lumbar interbody fusion system features a four-screw design and a locking cover plate designed to prevent screw backout.

Renovis’ Tesera implants are made using additive manufacturing, according to the company, and include a porous surface structure to enable bone attachment and in-growth to the implant.

With its latest regulatory win, Renovis’ portfolio of 3D-printed titanium implant systems include anterior cervical, anterior lumbar and posterior lumbar devices.

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Embolx wins FDA nod for next-gen Sniper balloon occlusion microcath

Embolx said today that it won FDA 510(k) clearance for its next-gen Sniper balloon occlusion microcatheters designed for pressure-directed arterial embolization therapy.

The Sunnyvale, Calif.-based company said that improvements to its next-gen Sniper microcath are intended to enhance access and navigation through small complex vascular structures. The catheter is available in 110 cm, 130 cm and 150 cm lengths to allow for access in either femoral or radial artery sites.

“The great thing about Sniper’s enhanced design and longer lengths is that it allows me to perform procedures using a transradial approach with the benefits of pressure-directed embolization. The ability to reverse blood flow using Sniper’s balloon helps me to not have to worry about non-target embolization. I can perform the procedure the way I want because of Sniper’s wide range compatibility with different guidewires, guide catheters, coils and therapeutic agents,” Dr. Aaron Fischman of the Icahn School of Medicine at Mount Sinai said in a prepared statement.

The Sniper Microcatheter is intended to alter blood flow dynamics by controlling pressure to allow for increased therapeutic agent delivery into target areas, and is currently used for treating cancerous tumors in the liver and other organs.

“Our next generation devices incorporate experience from more than 1,000 Sniper balloon occlusion microcatheters used to date. Now, interventional radiologists can do everything they would do with standard microcatheters, but with the added benefits of balloon occlusion. This is a big step forward and provides physicians with the most advanced transarterial delivery system for tumor and prostate treatment,” prez & CEO Michael Allen said in a press release.

In April, Embolx said that it landed a $2 million grant from the National Cancer Institute to fund development of its next-generation Sniper balloon occlusion microcatheter.

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