TAVI: Study finds low stroke rates with Medtronic’s CoreValve

A clinical study of nearly 1,000 patients implanted with Medtronic‘s (NYSE:MDT) CoreValve replacement heart valve found a low rate of stroke out to 2 years.

The study, published last month in the Journal of the American College of Cardiology, evaluated patients for neurological events over 3 periods after the procedure to implant the CoreValve transcatheter aortic valve implant: Periprocedural (0 to 1 days); early (2 to 30 days); and late (31 to 730 days).

Results from the 996-patient trial, “The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients,” showed an overall stroke rate of 1.4% for the 1st day. The rate of stroke was 3.0% at 30 days and 5.6% at 2 years, according to the study.

Although there were no significant predictors of periprocedural stroke or stroke/transient ischemic attack combined, the researchers found that acute kidney injury, major vascular complications and female gender were significant predictors of early stroke. Prior atrial fibrillation and major vascular complication predictive of for stroke/TIA combined, while coronary artery bypass graft surgery was the only significant predictor of late stroke, according to the study.

“Treatment of high-risk patients with aortic stenosis using a self-expandable system was associated with a low stroke rate at short- and long-term follow-up. Multivariable predictors of clinically relevant neurological events differed on the basis of the timing after TAVI,” the researchers wrote.

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SuperSonic Imagine aims to reduce biopsies with ultrasound

SuperSonic Imagine’s flagship device is the Aixplorer ultrasound imaging device which uses the company’s proprietary ShearWave elastography and UltraFast Doppler blood flow imaging.

Unlike other similar devices, SuperSonic’s uses software processing coupled with powerful processing boards produced by graphics company Nvidia, according to SuperSonic.

“Being able to simplify things changed the paradigm of the system, which is very much hardware centric, to a system where the intelligence is in the software. We built the software system – every function that is developed in hardware’s competitive environment is now in a software environment,” CEO Jacques Souquet told MassDevice.com in an interview

While the idea isn’t unique to SuperSonic, Souquet said it is a 1st in medical imaging. The device, running off software, is able to analyze up to 20,000 frames per second. The number is too high for a human to visualize, but allows the software to do more with the data, Souquet said.

“Now, you cannot visualize 20,000 frames per second, but this enables us to do lots of processing in the background to further enhance the performance of the product. It also enabled us to create a new mode of imaging on top of the conventional mode every ultrasound does. This new mode enables us to measure the stiffness of tissue,” Souquet said.

The new mode allows doctors, who normally manually diagnose stiff tissue through physical touch and pressure, to find stiff tissue with a non-invasive ultrasound imaging device and reduce the possibility of invasive biopsies to verify their diagnosis.

“We can do it in a reproducible way and we can do it in a quantitative way. We do not depend on the expertise or skill of a physician to do it, it’s entirely automatic,” Souquet said.

To test the technology’s potential, the company initially focused on early breast cancer detection.  In a clinical study, 1,800 patients were scanned with the device and the scans were compared with biopsies from the same patients.

Souquet said that through the trial, the company found the device was accurate, gave reproducible results and could more specifically characterize the lesions as benign or malignant without losing any sensitivity to stiff tissue on the whole.

“It’s important to look at the breast biopsies in the United States. There are around 2 million biopsies in the U.S. nowadays. Of those biopsies, in 80% of them there is no cancer found. So you submit the patients to lots of anxiety, and on top of that there’s added cost to healthcare, as breast biopsies are not always needle punctures and are sometimes surgical,” Souquet said.

The American College of Radiology now includes ShearWave scans in their guidelines for breast cancer detection with ultrasound, Souquet said.

SuperSonic has since expanded the reach of the device, including detecting liver fibrosis, screening for prostate cancer, and for vascular indications using UltraFast Doppler. The company is looking at expanding to gynecological indications as well.

The result of its expanded indications has been a severe reduction in biopsies, Souquet said. Baylor, Texas-based liver expert Dr. James Trotter has reported a 90% reduction in biopsies since adopting SuperSonic’s Aixplorer, according to the company.

This reduction in biopsies to screen for liver fibrosis is important to the company, Souquet said.

“Liver biopsies are very painful, and the amount of complications out of liver biopsies is very high. It’s important now, with the invention of drugs, such as Hepatitis C drugs, to be able to monitor the patient during treatment,” Souquet said.

Souquet said the company’s devices are in more than 1,000 facilities worldwide and hopes the number will continue to grow.

The company is developing a next-generation modular platform for the device, which would allow the company to sell to more segments on the ultrasound market, Souquet said.

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InVivo inks $50m financing deal

InVivo Therapeutics (OTC:NVIV) said last week it signed a sales agreement with Cowen and Company to sell up to $50,000,000 worth of shares in the company.

Under the agreement, Cowen and Company will receive 3% of gross proceeds from sales of the stock, Cambridge, Mass.-based InVivo said. InVivo will control the amount of shares sold.

The agreement can be terminated by either side, according to the spinal-focused medical device company.

In July, Invivo saw shares jump 10% after the company released promising data on the 2nd and 3rd patients implanted with its investigational neuro-spinal scaffold.

A 1-month checkup of the 3rd patient implanted with the scaffold reported an improvement from an A class injury on the American Spinal Injury Association Impairment Scale, indicating complete loss of sensory and motor function, to a B class on the AIS, indicating some restored sensory functions.

InVivo shares responded to the news by rising over 10%.

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Looking to change the game on rotator cuff repair: Rotation Medical’s Martha Shadan

Rotator cuff disease is one of the most common injuries in the world, with more than 3 million in the U.S. alone suffering damage to the tissues connecting muscle to bone in the shoulder.

But the standard treatment for rotator cuff disease is clunky, painful and often inefficient, with an estimated 40% of patients experiencing re-tearing of the rotator cuff following surgery.

For Rotation Medical, a Minnesota-based medical device company, that clinical gap presents a major window of opportunity.

Rotation’s treatment, a biologic implant derived from the achilles tendon of cows, is designed to spur new growth to thicken and strengthen the damaged tendon. Last year, the company raised more than $27 million in a Series B round to support a commercial launch and post-market clinical studies.

Rotation Medical CEO Martha Shadan recently sat down with MassDevice.com publisher Brian Johnson in another episode of DeviceTalks, to discuss the company’s treatment and how the orthopedic industry is changing forever:

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CR Bard’s Lutonix wins Medicare reimbursement add-on

C.R. Bard (NYSE:BCR) said today that angioplasty treatments with its Lutonix drug-coated balloon will now be eligible for add-on payments through the Centers for Medicare and Medicaid Services under Medicare’s hospital impatient prospective payment systems.

The add-on payment, with a maximum of $1,036, will help cover additional costs for treating patients with the Lutonix during inpatient settings and is slated to go into effect October 1, C.R. Bard said.

“After providing reimbursement in the outpatient setting earlier this year, CMS has now provided additional reimbursement for the Lutonix DCB in the inpatient setting, which demonstrates the benefit to patients from this breakthrough technology,” CEO Timothy Ring said in a prepared statement.

The Lutonix was the first DCB approved by the FDA, C.R. Bard said, and is used for the treatment of peripheral artery disease in the femoropopliteal arteries.

C.R. Bard posted a classic beat-&-raise 2nd quarter last week, topping both sales and earnings expectations and raising its outlook for the rest of the year.

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FDA raises medical device user fees more than 4%

The FDA is raising the user fees medical device makers pay for the safety watchdog to review its products by more than 4%.

The user fees for fiscal 2016, which begins Oct. 1, 2015 are going up 4.2% over the fiscal 2015 fees for both small businesses making less that $100 million annually and for their larger brethren, the FDA’s Center for Devices & Radiological Health said today.

The cuts are slated to cover applications for 510(k) clearance, the more stringent pre-market approval process and a raft of other applications to the FDA. The agency cut the fees by -2.9% for fiscal 2015, having raised them by 4.2% for FY2014.

The fiscal 2016 rates would see PMA applications cost $ for large companies (up from $250,895), with small-business PMAs running $ (up from $62,724). Applications for 510(k) clearances would cost $ (up from $5,018) for large firms and $ (up from $2,509) for small businesses. The new fees are slated to generate an estimated $137.7 million for the FDA, according to the Federal Register.

Here’s how this year’s changes break down:

Application type	Fee for FY16	Fee for FY15	Percentage increase	Small business fee FY16	Small business fee FY15	Percentage increase
510(k) premarket notification submission	$5,228	$5,018	4.2%	$2,614	$2,509	4.2%
513(g) request for classification information	$3,529	$3,387	4.2%	$1,765	$1,694	4.2%
PMA, PDP, PMR, BLA	$261,388	$250,895	4.2%	$65,347	$62,724	4.2%
Panel-track supplement	$196,041	$188,171	4.2%	$49,010	$47,043	4.2%
180-day supplement	$39,208	$37,634	4.2%	$9,802	$9,409	4.2%
Real-time supplement	$18,297	$17,563	4.2%	$4,574	$4,391	4.2%
Annual fee for periodic Class III reporting	$9,149	$8,781	4.2%	$2,287	$2,195	4.2%
30-day notice	$4,182	$4,014	4.2%	$2,091	$2,007	4.2%

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Covidien wants Supreme Court to hear appeal in $177m patent spat with Ethicon

Medtronic‘s (NYSE:MDT) Covidien subsidiary wants the U.S. Supreme Court to hear its appeal in a patent infringement case against Johnson & Johnson‘s (NYSE:JNJ) Ethicon Endo-Surgery unit over surgical shears.

In December 2014 the U.S. Court of Appeals for the Federal Circuit overturned a decision granting a $177 million award to Covidien in the U.S. District Court for Connecticut, where Judge Janet Bond Arterton had ruled that Ethicon Endo-Surgery infringed surgical shears patents held by Covidien’s corporate predecessors, Tyco Healthcare and U.S. Surgical Corp.

The Federal Circuit vacated the damages award, ruling that an Ethicon prototype anticipated the Covidien devices “because Ethicon conceived of the prototype before Tyco’s January 1997 conception date and diligently reduced it to practice without abandoning, suppressing, or concealing it thereafter,” Chief Judge Sharon Prost wrote for the 3-judge appeals panel. “The district court improperly held that the Ethicon prototype could not be considered prior art … and erred in finding that the curved blade claims and dual [cam] claims would not have been obvious.”

In a July 27 petition for certiorari from the high court, Covidien argued that the appeals court erred because the Ethicon prototype wasn’t complete or made public when Covidien patented its device.

“The Federal Circuit’s decision that such a secret conception can constitute prior art and thus invalidate a patent for obviousness contradicts the text of the statute, conflicts with this court’s prior decisions, and conflicts with the Federal Circuit’s own precedent,” Covidien argued, according to court documents. “Patentees must now defend the nonobviousness of their patents against a new universe of ‘prior’ art that post-dates their inventions.”

In October 2014, Covidien won an an injunction barring sales of Ethicon’s Harmonic Ace +7 shears from another federal judge in Connecticut, Judge Janet Hall, who declined to stay that proceeding pending the outcome of the Federal Circuit appeal in the 1st lawsuit. J&J has also appealed the injunction.

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