A Medical Device Daily

ATS Medical (Plymouth, Minnesota), a provider of cardiac surgery products and services, said the Australian Therapeutic Goods Administration has granted approval for commercialization of the ATS 3f Aortic Bioprosthesis, a tissue valve.

The company describes the 3f Aortic Bioprosthesis as "a revolutionary next-generation stentless pericardial aortic tissue valve that is unlike any other valve."

It said the primary benefit of the device is its tubular design, which restores continuity between the annulus and the sinotubular junction. "By restoring this continuity, the ATS 3f Aortic Bioprosthesis is the only aortic valve that preserves the aortic sinuses and restores native valve stress distribution and physiologic blood flow," ATS said.

It added that this valve design "provides surgeons and patients with a potentially more durable solution to aortic valve replacement."

ATS cited the more than six years of clinical experience with the valve, "confirming excellent safety and efficacy." It said the demonstrated clinical benefit and recent FDA approval of the ATS 3f Aortic Bioprosthesis "are creating excitement and product demand among U.S. surgeons."

ATS Medical is focusing on what it said are "two distinct but operationally synergistic market segments," those being heart valve disease therapy and surgical ablation of cardiac arrhythmias.

Originally founded to develop the ATS Open Pivot Heart Valve, ATS said it is building on the success of that mechanical heart valve in many markets around the world with the ATS 3f brand of tissue heart valves. It said that portfolio addresses conventional open surgery requirements, as well as what it termed "the growing demand for less invasive, sutureless-based procedures."

The company also offers the ATS Simulus annuloplasty product line, as well as ATS CryoMaze products for surgical cryoablation of cardiac arrhythmias.

1st installation in Mexico for Ablatherm

EDAP TMS (Lyon, France) reported the first installation of its Ablatherm-HIFU (high-intensity focused ultrasound) machine at Centro Medico Puerta de Hierro Hospital (Guadalajara, Mexico) under a revenue-per-procedure contract.

Dr. Jorge Gutierrez Aceves, MD, head of the Prostate Institute at Centro Medico Puerta de Hierro Hospital, said, "We are excited to be the first hospital in Mexico to launch and successfully perform Ablatherm-HIFU procedures. We see great promise for Ablatherm-HIFU as a targeted, minimally invasive treatment for localized prostate cancer and look forward to offering this treatment to more patients in the weeks to come.'"

Marc Oczachowski, EDAP's CEO, said, "The global expansion of Ablatherm-HIFU into key geographic markets has continued to drive adoption and positively impact EDAP's business. Our entrance into Mexico highlights EDAP's growth potential in the third-largest market in the Americas. We look forward to working with Dr. Gutierrez, a pioneer in introducing new innovative urological techniques in Mexico."

Oczachowski added that the Ablatherm device also has been approved in Brazil, "opening new opportunities for EDAP's business in Latin American. We are currently working closely with our distributor in Brazil to target clinical sites and offer the technology to those patients with prostate cancer in Brazil."

Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved in Europe and is currently undergoing evaluation in a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA.

The company also is developing the technology for the potential treatment of certain other types of tumors.

EDAP TMS also produces medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy.

Mexican distribution for SofPulse

In other Mexican med-tech news, Ivivi Technologies (Montvale, New Jersey), a maker of non-invasive electrotherapy systems, and Grupo Venta Internacional (GVI; Mexico City), a Mexican company dedicated to providing surgical equipment and other medical technology, reported that they have signed a distribution agreement.

The new agreement, which was effective Jan. 1, gives GVI the exclusive right to sell certain of Ivivi's targeted pulsed electromagnetic field (tPEMF) products in Mexico into the plastic and reconstructive surgery, maxillofacial surgery and cosmetic surgery markets, as well as to ear/nose/throat specialties, obstetric/gynecology specialties and hospitals.

GVI will purchase Ivivi's SofPulse and SofPulse Duo Disposable units at a specified price per unit and will be required to meet or exceed certain revenue/unit objectives. The agreement, which has a three-year term, also provides for a minimum opening order.

Gabriela Gonzalez, commercial director of GVI, said, "The SofPulse should provide an excellent addition to the suite of products we carry, especially for the aesthetics marketplace. Our key opinion leaders reviewed Ivivi's tPEMF technology and were particularly impressed with the documented clinical evidence. Last year, we provided equipment for more than 100,000 procedures in breast augmentation/reconstruction and liposuction. We believe the accelerated pain relief and anti-inflammatory effects seen with this product will be well received by patients who are anxious for a quick recovery."

The company's SofPulse products are FDA-cleared and are indicated for the adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.

MDS seeks to boost value

MDS (Toronto) reported that it has constituted a committee of independent directors to support the company's continuing process of reviewing alternatives to improve shareholder value. The board of directors is reviewing the performance of MDS and lookking for options to improve returns to shareholders.

Goldman, Sachs & Co. and RBC Capital Markets are assisting the company and the board as financial advisors.

MDS emphasized that there can be no assurance that the process will result in any specific strategic or financial transaction, especially given the uncertain market and current economic conditions. No timetable has been set for its completion.

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